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FDA 510(k)

SPECIAL PROCEDURES BASE UNIT MODEL 500

K-Number: K881713 · 1988-07-12

ApplicantGempco, Inc.
Decision Date1988-07-12
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPECIAL PROCEDURES BASE UNIT MODEL 500 is the device name listed in this FDA 510(k) record. The listed applicant is Gempco, Inc.. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K881713. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIAL PROCEDURES BASE UNIT MODEL 500?

SPECIAL PROCEDURES BASE UNIT MODEL 500 is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Gempco, Inc.. The 510(k) number is K881713.

When did SPECIAL PROCEDURES BASE UNIT MODEL 500 receive FDA 510(k) clearance?

SPECIAL PROCEDURES BASE UNIT MODEL 500 received FDA 510(k) clearance on 1988-07-12, under 510(k) number K881713.

Who is the listed applicant for SPECIAL PROCEDURES BASE UNIT MODEL 500?

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

What is the FDA product code for SPECIAL PROCEDURES BASE UNIT MODEL 500?

The FDA product code for SPECIAL PROCEDURES BASE UNIT MODEL 500 is FMT.

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Other records listing Gempco, 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.

K884283MODEL WC-107 MOBILE NEWBORN BEDK884280MODEL WC-102 NEWBORN BED & EQUIPMENT CABINETK884285MODEL WC-115 MOBILE BASSINET

Related Devices (Code: FMT)

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.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, 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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