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FDA 510(k)

MODEL 1301 BIOTAC (TM)

K-Number: K810627 · 1981-04-02

ApplicantProgress Mankind Technology
Decision Date1981-04-02
Product CodeGEA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 1301 BIOTAC (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Progress Mankind Technology. It received FDA 510(k) clearance on 1981-04-02 under 510(k) number K810627. The device is classified under product code GEA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1301 BIOTAC (TM)?

MODEL 1301 BIOTAC (TM) is a medical device that received FDA 510(k) clearance on 1981-04-02. The listed applicant is Progress Mankind Technology. The 510(k) number is K810627.

When did MODEL 1301 BIOTAC (TM) receive FDA 510(k) clearance?

MODEL 1301 BIOTAC (TM) received FDA 510(k) clearance on 1981-04-02, under 510(k) number K810627.

Who is the listed applicant for MODEL 1301 BIOTAC (TM)?

The FDA 510(k) record lists Progress Mankind Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 1301 BIOTAC (TM)?

The FDA product code for MODEL 1301 BIOTAC (TM) is GEA.

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Other records listing Progress Mankind Technology 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.

K883314PMT 3721-1 EPIDURAL KITK881616PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1K871663PMT TRACTION TONGSK854157PMT ACCUPRESSURE INFUSION SYSTEM 3601K845035ELECTRODE FOR NEUROLOGICAL SURGERY 2111K845036TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600

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Related Devices (Code: GEA)

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.

K003965MRI SAFE INSTRUMENTSAesculap, Inc.K982472GENICON TROCARGenicon, LCK954599CONMED TROGARD ELECTRONIC TROCAR SYSTEMConmedcorpK922460ORIGIN SECONDARY CANNULA AND TROCAROrigin Medsystems, Inc.K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEETHICON, Inc.K911262DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCERETHICON, 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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