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Invacare Platinum Mobile Oxygen Concentrator

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K160630

by Invacare Corporation

Identity

Trade Name
Invacare® Platinum® Mobile Oxygen Concentrator FDA UDI
Generic Name
Mobile/portable oxygen concentrator FDA UDI
Device Name
Invacare POC1-100B Platinum Mobile Oxygen Concentrator FDA UDI
Model / Reference
POC1-100BAMZ FDA UDI
Description
Invacare POC1-100B Platinum Mobile Oxygen Concentrator FDA UDI

Identifiers

Catalog Number
POC1-100BAMZ FDA UDI
Primary DI / UDI-DI
00841447103400 FDA UDI
510(k) Number
K160630 FDA 510(k)FDA UDI
FDA Product Code
CAW FDA 510(k)FDA UDI
GMDN Term
Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 868.5440 FDA 510(k)
Regulation Number
868.5440 FDA 510(k)FDA UDI
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

FDA UDI

Invacare Platinum Mobile Oxygen Concentrator by Invacare Corporation — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Invacare Corporation

Sources (2)

  • FDA 510(k) K160630 24 fields · synced Jun 19, 2026
  • FDA UDI 69ceeb34-4cb3-4e5a-acc8-7cc319a0721a 36 fields · synced May 26, 2026