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FDA 510(k)

PDS MODEL 3000 ADULT RESPIRATION MODULE

K-Number: K802046 · 1980-09-16

ApplicantGeneral Electric Co.
Decision Date1980-09-16
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PDS MODEL 3000 ADULT RESPIRATION MODULE is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802046. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDS MODEL 3000 ADULT RESPIRATION MODULE?

PDS MODEL 3000 ADULT RESPIRATION MODULE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is General Electric Co.. The 510(k) number is K802046.

When did PDS MODEL 3000 ADULT RESPIRATION MODULE receive FDA 510(k) clearance?

PDS MODEL 3000 ADULT RESPIRATION MODULE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802046.

Who is the listed applicant for PDS MODEL 3000 ADULT RESPIRATION MODULE?

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

What is the FDA product code for PDS MODEL 3000 ADULT RESPIRATION MODULE?

The FDA product code for PDS MODEL 3000 ADULT RESPIRATION MODULE is BZQ.

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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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