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FDA 510(k)

ROOMATE II

K-Number: K822789 · 1982-10-15

ApplicantCryogenic Assoc.
Decision Date1982-10-15
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROOMATE II is the device name listed in this FDA 510(k) record. The listed applicant is Cryogenic Assoc.. It received FDA 510(k) clearance on 1982-10-15 under 510(k) number K822789. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOMATE II?

ROOMATE II is a medical device that received FDA 510(k) clearance on 1982-10-15. The listed applicant is Cryogenic Assoc.. The 510(k) number is K822789.

When did ROOMATE II receive FDA 510(k) clearance?

ROOMATE II received FDA 510(k) clearance on 1982-10-15, under 510(k) number K822789.

Who is the listed applicant for ROOMATE II?

The FDA 510(k) record lists Cryogenic Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROOMATE II?

The FDA product code for ROOMATE II is CAW.

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Other records listing Cryogenic Assoc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K883590OXYTROLK852663PORTABLE GASEOUS OXGYEN CONTAINERK841808STROLLER SPRINTK800742LIBERATOR/STROLLER II SYSTEMK801104ROOMMATE-OXYGEN CONCENTRATOR

Related Devices (Code: CAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

Official Source

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