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FDA 510(k)

PULSAIR I & II

K-Number: K833994 · 1983-12-12

ApplicantCryo Corp.
Decision Date1983-12-12
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULSAIR I & II is the device name listed in this FDA 510(k) record. The listed applicant is Cryo Corp.. It received FDA 510(k) clearance on 1983-12-12 under 510(k) number K833994. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSAIR I & II?

PULSAIR I & II is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Cryo Corp.. The 510(k) number is K833994.

When did PULSAIR I & II receive FDA 510(k) clearance?

PULSAIR I & II received FDA 510(k) clearance on 1983-12-12, under 510(k) number K833994.

Who is the listed applicant for PULSAIR I & II?

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

What is the FDA product code for PULSAIR I & II?

The FDA product code for PULSAIR I & II is BYJ.

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 Cryo Corp. 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.

K872145CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)K834569VENTILATORY FREQUENCY MONITOR

Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, 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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