Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AQUA-BLANKET HYPER/HYPOHERMIA BLANKET

K-Number: K890852 · 1989-04-14

ApplicantAti
Decision Date1989-04-14
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AQUA-BLANKET HYPER/HYPOHERMIA BLANKET is the device name listed in this FDA 510(k) record. The listed applicant is Ati. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K890852. 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 AQUA-BLANKET HYPER/HYPOHERMIA BLANKET?

AQUA-BLANKET HYPER/HYPOHERMIA BLANKET is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Ati. The 510(k) number is K890852.

When did AQUA-BLANKET HYPER/HYPOHERMIA BLANKET receive FDA 510(k) clearance?

AQUA-BLANKET HYPER/HYPOHERMIA BLANKET received FDA 510(k) clearance on 1989-04-14, under 510(k) number K890852.

Who is the listed applicant for AQUA-BLANKET HYPER/HYPOHERMIA BLANKET?

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

What is the FDA product code for AQUA-BLANKET HYPER/HYPOHERMIA BLANKET?

The FDA product code for AQUA-BLANKET HYPER/HYPOHERMIA BLANKET 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 Ati 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.

K902344ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STERK890853AQUA-PAD FOR MOIST OR DRY HEAT THERAPY

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

View on FDA Database →

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

↑