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FDA 510(k)

OPEN HEART TRAY

K-Number: K912053 · 1991-08-26

ApplicantMedical Device Inspection Co., Inc.
Decision Date1991-08-26
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPEN HEART TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Inspection Co., Inc.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K912053. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPEN HEART TRAY?

OPEN HEART TRAY is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Medical Device Inspection Co., Inc.. The 510(k) number is K912053.

When did OPEN HEART TRAY receive FDA 510(k) clearance?

OPEN HEART TRAY received FDA 510(k) clearance on 1991-08-26, under 510(k) number K912053.

Who is the listed applicant for OPEN HEART TRAY?

The FDA 510(k) record lists Medical Device Inspection Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPEN HEART TRAY?

The FDA product code for OPEN HEART TRAY is FSM.

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Other records listing Medical Device Inspection Co., 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.

K945826J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONSK932072JARIT SURGICAL INSTRUMENTSK931594THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEMK933580POWER WORK TABLEK933578POWERMATIC MAT PLATFORMK933581POWERMATIC TREATMENT TABLE

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Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.K912104MAJOR BASIN TRAYMedical Device Inspection Co., 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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