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FDA 510(k)

PB-4 REPLAY UNIT

K-Number: K790289 · 1979-02-27

ApplicantOxford Medilog, Inc.
Decision Date1979-02-27
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PB-4 REPLAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Medilog, Inc.. It received FDA 510(k) clearance on 1979-02-27 under 510(k) number K790289. 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 PB-4 REPLAY UNIT?

PB-4 REPLAY UNIT is a medical device that received FDA 510(k) clearance on 1979-02-27. The listed applicant is Oxford Medilog, Inc.. The 510(k) number is K790289.

When did PB-4 REPLAY UNIT receive FDA 510(k) clearance?

PB-4 REPLAY UNIT received FDA 510(k) clearance on 1979-02-27, under 510(k) number K790289.

Who is the listed applicant for PB-4 REPLAY UNIT?

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

What is the FDA product code for PB-4 REPLAY UNIT?

The FDA product code for PB-4 REPLAY UNIT 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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