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FDA 510(k)

MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS

K-Number: K905207 · 1991-01-22

ApplicantMicro Surgical Instruments Corp.
Decision Date1991-01-22
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Micro Surgical Instruments Corp.. It received FDA 510(k) clearance on 1991-01-22 under 510(k) number K905207. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS?

MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS is a medical device that received FDA 510(k) clearance on 1991-01-22. The listed applicant is Micro Surgical Instruments Corp.. The 510(k) number is K905207.

When did MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS receive FDA 510(k) clearance?

MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS received FDA 510(k) clearance on 1991-01-22, under 510(k) number K905207.

Who is the listed applicant for MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS?

The FDA 510(k) record lists Micro Surgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS?

The FDA product code for MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS is IME.

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Other records listing Micro Surgical Instruments Corp. 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.

K931395SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEMK932492IMPLANTOLOGY MODULE, MODEL 2175K930205ELECTRIC WIRE DRIVER, MODEL 2640EK914998MICROAIRE(R) FACIAL BONE PLATING SYSTEMK915139MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULEK914346DRILL MODULES MODELS 2116/2117

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Related Devices (Code: IME)

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.

K923627COLD PACKFriendmed ProductsK915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.K832193NICE PACKUniversal Medical Instrument Corp.

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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