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FDA 510(k)

ERG 555 COUCH ERGOMETER

K-Number: K854493 · 1986-06-16

ApplicantRobert Bosch Corp.
Decision Date1986-06-16
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ERG 555 COUCH ERGOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Robert Bosch Corp.. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K854493. 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 ERG 555 COUCH ERGOMETER?

ERG 555 COUCH ERGOMETER is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Robert Bosch Corp.. The 510(k) number is K854493.

When did ERG 555 COUCH ERGOMETER receive FDA 510(k) clearance?

ERG 555 COUCH ERGOMETER received FDA 510(k) clearance on 1986-06-16, under 510(k) number K854493.

Who is the listed applicant for ERG 555 COUCH ERGOMETER?

The FDA 510(k) record lists Robert Bosch Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERG 555 COUCH ERGOMETER?

The FDA product code for ERG 555 COUCH ERGOMETER is DRT.

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Other records listing Robert Bosch Corp. 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.

K854492ERG 551 ERGOMETER, BICYCLEK854491ERG 550 ERGOMETER BICYCLEK853541SP 4K853154HV-4K853271HEARING AID ANALYSIS SYSTEMK851485DEFI 502

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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

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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