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FDA 510(k)

SOFT-COVER

K-Number: K921928 · 1992-11-06

ApplicantAdroit Medical Systems, Inc.
Decision Date1992-11-06
Product CodeFMW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOFT-COVER is the device name listed in this FDA 510(k) record. The listed applicant is Adroit Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K921928. The device is classified under product code FMW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT-COVER?

SOFT-COVER is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Adroit Medical Systems, Inc.. The 510(k) number is K921928.

When did SOFT-COVER receive FDA 510(k) clearance?

SOFT-COVER received FDA 510(k) clearance on 1992-11-06, under 510(k) number K921928.

Who is the listed applicant for SOFT-COVER?

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

What is the FDA product code for SOFT-COVER?

The FDA product code for SOFT-COVER is FMW.

Related Clinical Trials

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Other records listing Adroit Medical 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.

K073712SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100K973981SAFEPASS STERILIZATION POUCHK970197HTP-1500 LOCALIZED HEAT THERAPY PUMPK962983STERILE SOFT-TEMPK921920SOFT-TEMP

Related Devices (Code: FMW)

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.

K152884DermaTherapy Bed LinensPrecision Fabrics Group, Inc.K061242DERMATHERAPY, MODEL 22216Precision Fabrics Group, Inc.K001003Z-NETDemite LimitedK992702EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEMAllergy DirectK940327INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOWW. L. Gore & Associates, Inc.K935220CORE PREVENT MATTRESS MODIFICATIONPaladin Medical, 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.

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