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FDA 510(k)

HEART HUGGER STERNUM SUPPORT HARNESS

K-Number: K882592 · 1988-09-20

ApplicantGeneral Cardiac Technology, Inc.
Decision Date1988-09-20
Product CodeKMO
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEART HUGGER STERNUM SUPPORT HARNESS is the device name listed in this FDA 510(k) record. The listed applicant is General Cardiac Technology, Inc.. It received FDA 510(k) clearance on 1988-09-20 under 510(k) number K882592. The device is classified under product code KMO. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART HUGGER STERNUM SUPPORT HARNESS?

HEART HUGGER STERNUM SUPPORT HARNESS is a medical device that received FDA 510(k) clearance on 1988-09-20. The listed applicant is General Cardiac Technology, Inc.. The 510(k) number is K882592.

When did HEART HUGGER STERNUM SUPPORT HARNESS receive FDA 510(k) clearance?

HEART HUGGER STERNUM SUPPORT HARNESS received FDA 510(k) clearance on 1988-09-20, under 510(k) number K882592.

Who is the listed applicant for HEART HUGGER STERNUM SUPPORT HARNESS?

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

What is the FDA product code for HEART HUGGER STERNUM SUPPORT HARNESS?

The FDA product code for HEART HUGGER STERNUM SUPPORT HARNESS is KMO.

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Related Devices (Code: KMO)

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.

K9218524 SURE TM RECTAL TUBEBoston Pacific Medical, Inc.K893809COUGH PILLOWCustom Hospitals ProductsK883214THORACIC SUPPORT SYSTEMStorer Medical ProductsK792629STERILIZATION PROCESS/T-BINDERProcter & Gamble Mfg. Co.

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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