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FDA 510(k)

ELECTRO-PLETHYSMOGRAPH

K-Number: K780761 · 1978-06-30

ApplicantBiotecx Laboratories, Inc.
Decision Date1978-06-30
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRO-PLETHYSMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-30 under 510(k) number K780761. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO-PLETHYSMOGRAPH?

ELECTRO-PLETHYSMOGRAPH is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K780761.

When did ELECTRO-PLETHYSMOGRAPH receive FDA 510(k) clearance?

ELECTRO-PLETHYSMOGRAPH received FDA 510(k) clearance on 1978-06-30, under 510(k) number K780761.

Who is the listed applicant for ELECTRO-PLETHYSMOGRAPH?

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

What is the FDA product code for ELECTRO-PLETHYSMOGRAPH?

The FDA product code for ELECTRO-PLETHYSMOGRAPH is JOM.

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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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