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FDA 510(k)

CARDIO-PAK LAPAROTOMY PACK

K-Number: K923233 · 1993-03-20

ApplicantCardio-Med-Associates, Inc.
Decision Date1993-03-20
Product CodeFZH
Advisory CommitteeSU
DecisionUnknown

Device Summary

CARDIO-PAK LAPAROTOMY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Med-Associates, Inc.. It received FDA 510(k) clearance on 1993-03-20 under 510(k) number K923233. The device is classified under product code FZH. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CARDIO-PAK LAPAROTOMY PACK?

CARDIO-PAK LAPAROTOMY PACK is a medical device that received FDA 510(k) clearance on 1993-03-20. The listed applicant is Cardio-Med-Associates, Inc.. The 510(k) number is K923233.

When did CARDIO-PAK LAPAROTOMY PACK receive FDA 510(k) clearance?

CARDIO-PAK LAPAROTOMY PACK received FDA 510(k) clearance on 1993-03-20, under 510(k) number K923233.

Who is the listed applicant for CARDIO-PAK LAPAROTOMY PACK?

The FDA 510(k) record lists Cardio-Med-Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO-PAK LAPAROTOMY PACK?

The FDA product code for CARDIO-PAK LAPAROTOMY PACK is FZH.

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.

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Other records listing Cardio-Med-Associates, 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.

K923231CARDIO-PAK BASIC PUMP PACK

Related Devices (Code: FZH)

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.

K875305MODEL UCA / SPEC SYSTEM UCASpec Systems, Inc.K871901ULTRAFLOWCustom Industries, Inc.K770084OPERATING ROOM VENTILATORDupaco, Inc.

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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