MedtechSourcebook

Spacelabs Healthcare Inc.

Contract manufacturer · Snoqualmie, WA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3010157426 (openFDA record; or search FDA's registration database)
FEI number
3010157426
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
SPACELABS HEALTHCARE, INC. (FDA owner/operator no. 2022906)
Registered address
35301 SE Center St, Snoqualmie, WA 98065
Contract listings
13 device listings, 8 product codes, first listed Jan 8, 1998
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
BSZGas-Machine, AnesthesiaClass IIAnesthesiologyContract manufacturingAug 1, 2008
CBKVentilator, Continuous, Facility UseClass IIAnesthesiologyContract manufacturingApr 10, 2012
DPSElectrocardiographClass IICardiovascularContract manufacturingDec 17, 2007
DQKComputer, Diagnostic, ProgrammableClass IICardiovascularContract manufacturingMay 4, 2012
DXHTransmitters And Receivers, Electrocardiograph, TelephoneClass IICardiovascularContract manufacturingJan 8, 1998
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveClass IICardiovascularContract manufacturingOct 19, 2011
MNRVentilatory Effort RecorderClass IIAnesthesiologyContract manufacturingMay 4, 2012
MWJElectrocardiograph, Ambulatory (Without Analysis)Class IICardiovascularContract manufacturingAug 21, 2003