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FDA 510(k)

HYPERDERMIC NEEDLE WITH SENSOR #514

K-Number: K791462 · 1979-09-24

ApplicantMedtech Intl., Inc.
Decision Date1979-09-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPERDERMIC NEEDLE WITH SENSOR #514 is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Intl., Inc.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791462. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERDERMIC NEEDLE WITH SENSOR #514?

HYPERDERMIC NEEDLE WITH SENSOR #514 is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Medtech Intl., Inc.. The 510(k) number is K791462.

When did HYPERDERMIC NEEDLE WITH SENSOR #514 receive FDA 510(k) clearance?

HYPERDERMIC NEEDLE WITH SENSOR #514 received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791462.

Who is the listed applicant for HYPERDERMIC NEEDLE WITH SENSOR #514?

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

What is the FDA product code for HYPERDERMIC NEEDLE WITH SENSOR #514?

The FDA product code for HYPERDERMIC NEEDLE WITH SENSOR #514 is FMI.

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Other records listing Medtech Intl., Inc. as applicant

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K920876CUT RESISTANT GLOVES OR SURGICAL GLOVE LINERK853843IV MATEK790467SURGICAL EYE SPONGEK790389GAUZE & COTTON SPONGESK781157STIMULATOR, NERVE, TRANSCUTANEOUS

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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