Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ERA-20

K-Number: K853194 · 1987-03-11

ApplicantBiotronik Sales, Inc.
Decision Date1987-03-11
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ERA-20 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik Sales, Inc.. It received FDA 510(k) clearance on 1987-03-11 under 510(k) number K853194. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERA-20?

ERA-20 is a medical device that received FDA 510(k) clearance on 1987-03-11. The listed applicant is Biotronik Sales, Inc.. The 510(k) number is K853194.

When did ERA-20 receive FDA 510(k) clearance?

ERA-20 received FDA 510(k) clearance on 1987-03-11, under 510(k) number K853194.

Who is the listed applicant for ERA-20?

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

What is the FDA product code for ERA-20?

The FDA product code for ERA-20 is DTE.

Other records listing Biotronik Sales, 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.

K875199NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTORK860036EDP-20 PACEMAKERK863878TRIOS-M VS-1 PULSE GENERATORK863879NEOS-M VS-1 PULSE GENERATORK863480BIOTRONIK PERMANENT PACEMAKER ELECTRODEK860921NEOS VS-1, PULSE GENERATOR

View all 41 devices →

Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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.

↑