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FDA 510(k)

LOW AIR LOSS MATTRESS, MODIFICATION

K-Number: K934689 · 1994-02-02

ApplicantCardio Systems, Inc.
Decision Date1994-02-02
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LOW AIR LOSS MATTRESS, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Systems, Inc.. It received FDA 510(k) clearance on 1994-02-02 under 510(k) number K934689. 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 LOW AIR LOSS MATTRESS, MODIFICATION?

LOW AIR LOSS MATTRESS, MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-02-02. The listed applicant is Cardio Systems, Inc.. The 510(k) number is K934689.

When did LOW AIR LOSS MATTRESS, MODIFICATION receive FDA 510(k) clearance?

LOW AIR LOSS MATTRESS, MODIFICATION received FDA 510(k) clearance on 1994-02-02, under 510(k) number K934689.

Who is the listed applicant for LOW AIR LOSS MATTRESS, MODIFICATION?

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

What is the FDA product code for LOW AIR LOSS MATTRESS, MODIFICATION?

The FDA product code for LOW AIR LOSS MATTRESS, MODIFICATION is INX.

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Other records listing Cardio Systems, Inc. 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.

K131092STEALTH 360 ORBITAL PAD SYSTEMK081944MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEMK972022ZAK-2000K921500CENTRI-SAFE(TM) VALVEK882177ADD-ON TO CRITICAL PATIENT CARE BEDK852736BAYLOR RAPID AUTOTRANSFUSION SYSTEM

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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.K924973DYLNAMEDICS A.S.A.P.Dynamedics, Inc.

Official Source

View on FDA Database →

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

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