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FDA 510(k)

COLLINS PEDALMATE 2

K-Number: K781889 · 1978-11-22

ApplicantWarren E. Collins, Inc.
Decision Date1978-11-22
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLLINS PEDALMATE 2 is the device name listed in this FDA 510(k) record. The listed applicant is Warren E. Collins, Inc.. It received FDA 510(k) clearance on 1978-11-22 under 510(k) number K781889. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLINS PEDALMATE 2?

COLLINS PEDALMATE 2 is a medical device that received FDA 510(k) clearance on 1978-11-22. The listed applicant is Warren E. Collins, Inc.. The 510(k) number is K781889.

When did COLLINS PEDALMATE 2 receive FDA 510(k) clearance?

COLLINS PEDALMATE 2 received FDA 510(k) clearance on 1978-11-22, under 510(k) number K781889.

Who is the listed applicant for COLLINS PEDALMATE 2?

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

What is the FDA product code for COLLINS PEDALMATE 2?

The FDA product code for COLLINS PEDALMATE 2 is ISD.

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Other records listing Warren E. Collins, 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.

K925459GS-MODULAR (GOLD STANDARD - MODULAR)K912946COLLINS DIGITAL PULMONARY MANOMETERK871151THE SPIRA ELEKTRO 2K861227COLLINS PNEUMOTACH PFT SYSTEMK852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMK831780METABOLIC EXERCISE TESTING SYSTEM

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Related Devices (Code: ISD)

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.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K112121ERGOSELECT/GEErgoline GmbHK080545ACTITRAINERActigraph, LLCK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, 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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