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FDA 510(k)

CLA-1400 SYSTEM

K-Number: K914851 · 1991-11-13

ApplicantGaymar Industries, Inc.
Decision Date1991-11-13
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CLA-1400 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K914851. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLA-1400 SYSTEM?

CLA-1400 SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K914851.

When did CLA-1400 SYSTEM receive FDA 510(k) clearance?

CLA-1400 SYSTEM received FDA 510(k) clearance on 1991-11-13, under 510(k) number K914851.

Who is the listed applicant for CLA-1400 SYSTEM?

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

What is the FDA product code for CLA-1400 SYSTEM?

The FDA product code for CLA-1400 SYSTEM is IOQ.

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Other records listing Gaymar Industries, 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.

K100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPK962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMK963067SOF. PRESS EPC 51 SYSTEMK961854SPR PLUS II OVERLAY SYSTEM (CL250/CL212K942881TC 3000

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Related Devices (Code: IOQ)

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.

K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-RomK973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist ProductsK970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, 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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