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Spacelabs Healthcare

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Spacelabs Healthcare FDA UDI
Generic Name
Multiple vital physiological parameter monitoring system, clinical FDA UDI
Device Name
OPTION,SPACELABS SPO2 FDA UDI
Model / Reference
Elance FDA UDI
Description
OPTION,SPACELABS SPO2 FDA UDI

Identifiers

Catalog Number
93300-S FDA UDI
Primary DI / UDI-DI
10841522128479 FDA UDI
510(k) Number
K150329 FDA UDI
FDA Product Code
MHX FDA UDI
GMDN Term
Multiple vital physiological parameter monitoring system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, clinical.

Cleared under the same submission

K150329 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI 5df61004-060f-4cef-8809-62462f7c18c5 36 fields · synced May 30, 2026