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FDA 510(k)

ELCAT D-PPG, PLETHYSMOGRAPH DEVICE

K-Number: K944395 · 1995-05-10

ApplicantDermatology Assoc.
Decision Date1995-05-10
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELCAT D-PPG, PLETHYSMOGRAPH DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Dermatology Assoc.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K944395. 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 ELCAT D-PPG, PLETHYSMOGRAPH DEVICE?

ELCAT D-PPG, PLETHYSMOGRAPH DEVICE is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Dermatology Assoc.. The 510(k) number is K944395.

When did ELCAT D-PPG, PLETHYSMOGRAPH DEVICE receive FDA 510(k) clearance?

ELCAT D-PPG, PLETHYSMOGRAPH DEVICE received FDA 510(k) clearance on 1995-05-10, under 510(k) number K944395.

Who is the listed applicant for ELCAT D-PPG, PLETHYSMOGRAPH DEVICE?

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

What is the FDA product code for ELCAT D-PPG, PLETHYSMOGRAPH DEVICE?

The FDA product code for ELCAT D-PPG, PLETHYSMOGRAPH DEVICE is JOM.

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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.

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