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FDA 510(k)

COACH TM- THE AEROBIC FITNESS MONITOR

K-Number: K851335 · 1985-07-24

ApplicantBiotechnology, Inc.
Decision Date1985-07-24
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COACH TM- THE AEROBIC FITNESS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biotechnology, Inc.. It received FDA 510(k) clearance on 1985-07-24 under 510(k) number K851335. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COACH TM- THE AEROBIC FITNESS MONITOR?

COACH TM- THE AEROBIC FITNESS MONITOR is a medical device that received FDA 510(k) clearance on 1985-07-24. The listed applicant is Biotechnology, Inc.. The 510(k) number is K851335.

When did COACH TM- THE AEROBIC FITNESS MONITOR receive FDA 510(k) clearance?

COACH TM- THE AEROBIC FITNESS MONITOR received FDA 510(k) clearance on 1985-07-24, under 510(k) number K851335.

Who is the listed applicant for COACH TM- THE AEROBIC FITNESS MONITOR?

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

What is the FDA product code for COACH TM- THE AEROBIC FITNESS MONITOR?

The FDA product code for COACH TM- THE AEROBIC FITNESS MONITOR is DRT.

Related Clinical Trials

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.

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Other records listing Biotechnology, 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.

K831752BIOCHECK PEC-108 PROGRAM-PULSE MONITOR

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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