FDA 510(k)

ERA 2000A

K-Number: K911261 · 1991-05-31

Decision Date1991-05-31

Product CodeBTL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ERA 2000A is the device name listed in this FDA 510(k) record. The listed applicant is Neotronics, Inc.. It received FDA 510(k) clearance on 1991-05-31 under 510(k) number K911261. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERA 2000A?

ERA 2000A is a medical device that received FDA 510(k) clearance on 1991-05-31. The listed applicant is Neotronics, Inc.. The 510(k) number is K911261.

When did ERA 2000A receive FDA 510(k) clearance?

ERA 2000A received FDA 510(k) clearance on 1991-05-31, under 510(k) number K911261.

Who is the listed applicant for ERA 2000A?

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

What is the FDA product code for ERA 2000A?

The FDA product code for ERA 2000A is BTL.

Other records listing Neotronics, 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.

K801607MOM 2

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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.