FDA 510(k)

ERM-101

K-Number: K781407 · 1978-09-27

Decision Date1978-09-27

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ERM-101 is the device name listed in this FDA 510(k) record. The listed applicant is Cynergy. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781407. 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 ERM-101?

ERM-101 is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Cynergy. The 510(k) number is K781407.

When did ERM-101 receive FDA 510(k) clearance?

ERM-101 received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781407.

Who is the listed applicant for ERM-101?

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

What is the FDA product code for ERM-101?

The FDA product code for ERM-101 is DRT.

Other records listing Cynergy 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.

K810566SIEMENS MODEL 146-146A EXTERNAL PULSE G K801596CYNERGY MODEL 184 K792536CYNERGY MODEL 182 K792223PACESETTER MODEL 350

Related Devices (Code: DRT)

K254058DistaSense(TM) (v1)Life Detection Technologies K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003The 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.