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FDA 510(k)

MONARK ERGOMETERS

K-Number: K912227 · 1991-08-07

ApplicantQuinton, Inc.
Decision Date1991-08-07
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MONARK ERGOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1991-08-07 under 510(k) number K912227. 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 MONARK ERGOMETERS?

MONARK ERGOMETERS is a medical device that received FDA 510(k) clearance on 1991-08-07. The listed applicant is Quinton, Inc.. The 510(k) number is K912227.

When did MONARK ERGOMETERS receive FDA 510(k) clearance?

MONARK ERGOMETERS received FDA 510(k) clearance on 1991-08-07, under 510(k) number K912227.

Who is the listed applicant for MONARK ERGOMETERS?

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

What is the FDA product code for MONARK ERGOMETERS?

The FDA product code for MONARK ERGOMETERS is ISD.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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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