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FDA 510(k)

PFT CALIBRATOR

K-Number: K801597 · 1980-08-04

ApplicantSpital Medical, Inc.
Decision Date1980-08-04
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PFT CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Spital Medical, Inc.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801597. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PFT CALIBRATOR?

PFT CALIBRATOR is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Spital Medical, Inc.. The 510(k) number is K801597.

When did PFT CALIBRATOR receive FDA 510(k) clearance?

PFT CALIBRATOR received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801597.

Who is the listed applicant for PFT CALIBRATOR?

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

What is the FDA product code for PFT CALIBRATOR?

The FDA product code for PFT CALIBRATOR is BZC.

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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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