FDA 510(k)

REM-AIR

K-Number: K924686 · 1993-02-12

Decision Date1993-02-12

Product CodeINX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

REM-AIR is the device name listed in this FDA 510(k) record. The listed applicant is Mellenair Ent., Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K924686. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REM-AIR?

REM-AIR is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Mellenair Ent., Inc.. The 510(k) number is K924686.

When did REM-AIR receive FDA 510(k) clearance?

REM-AIR received FDA 510(k) clearance on 1993-02-12, under 510(k) number K924686.

Who is the listed applicant for REM-AIR?

The FDA 510(k) record lists Mellenair Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REM-AIR?

The FDA product code for REM-AIR is INX.

Related Devices (Code: INX)

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.

K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K964223CLINITRON RITE-HITEHill-Rom, Inc.K943385CLINITRON ELEXISSsi Medical Services, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.