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FDA 510(k)

STERILE SOFT-TEMP

K-Number: K962983 · 1997-01-10

ApplicantAdroit Medical Systems, Inc.
Decision Date1997-01-10
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STERILE SOFT-TEMP 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 1997-01-10 under 510(k) number K962983. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SOFT-TEMP?

STERILE SOFT-TEMP is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Adroit Medical Systems, Inc.. The 510(k) number is K962983.

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

STERILE SOFT-TEMP received FDA 510(k) clearance on 1997-01-10, under 510(k) number K962983.

Who is the listed applicant for STERILE SOFT-TEMP?

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 STERILE SOFT-TEMP?

The FDA product code for STERILE SOFT-TEMP is ILO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 PUMPK921920SOFT-TEMPK921928SOFT-COVER

Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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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