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FDA 510(k)

PFT GASES

K-Number: K781523 · 1978-12-01

ApplicantGardner Cryogenics
Decision Date1978-12-01
Product CodeBXY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PFT GASES is the device name listed in this FDA 510(k) record. The listed applicant is Gardner Cryogenics. It received FDA 510(k) clearance on 1978-12-01 under 510(k) number K781523. The device is classified under product code BXY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PFT GASES?

PFT GASES is a medical device that received FDA 510(k) clearance on 1978-12-01. The listed applicant is Gardner Cryogenics. The 510(k) number is K781523.

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

PFT GASES received FDA 510(k) clearance on 1978-12-01, under 510(k) number K781523.

Who is the listed applicant for PFT GASES?

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

What is the FDA product code for PFT GASES?

The FDA product code for PFT GASES is BXY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Gardner Cryogenics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K770494BLOOD GAS ANALYZER-CALIBRATION GAS

Related Devices (Code: BXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953506WESTMED RESPIRATORY LUER ADAPTORWestmed Intl.K902916PRECISION MEDICAL NEB BLOCKPrecision Medical, Inc.K902917PRECISION MEDICAL ELIMINATORPrecision Medical, Inc.K863510OXY-OFF(TM)B&B Medical Technologies, Inc.K860516LSP MINILATORLife Support Products, Inc.K851460NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLATelectronics, Inc.

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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