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FDA 510(k)

SERIES 7000/HOLTER RECORDER

K-Number: K851971 · 1985-06-20

ApplicantPfizer, Inc.
Decision Date1985-06-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SERIES 7000/HOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1985-06-20 under 510(k) number K851971. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 7000/HOLTER RECORDER?

SERIES 7000/HOLTER RECORDER is a medical device that received FDA 510(k) clearance on 1985-06-20. The listed applicant is Pfizer, Inc.. The 510(k) number is K851971.

When did SERIES 7000/HOLTER RECORDER receive FDA 510(k) clearance?

SERIES 7000/HOLTER RECORDER received FDA 510(k) clearance on 1985-06-20, under 510(k) number K851971.

Who is the listed applicant for SERIES 7000/HOLTER RECORDER?

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

What is the FDA product code for SERIES 7000/HOLTER RECORDER?

The FDA product code for SERIES 7000/HOLTER RECORDER is DSH.

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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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