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FDA 510(k)

PATIENT VALVE WITH AIR ENTRAINMENT

K-Number: K863410 · 1987-01-12

ApplicantPneupac , Ltd.
Decision Date1987-01-12
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PATIENT VALVE WITH AIR ENTRAINMENT is the device name listed in this FDA 510(k) record. The listed applicant is Pneupac , Ltd.. It received FDA 510(k) clearance on 1987-01-12 under 510(k) number K863410. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT VALVE WITH AIR ENTRAINMENT?

PATIENT VALVE WITH AIR ENTRAINMENT is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Pneupac , Ltd.. The 510(k) number is K863410.

When did PATIENT VALVE WITH AIR ENTRAINMENT receive FDA 510(k) clearance?

PATIENT VALVE WITH AIR ENTRAINMENT received FDA 510(k) clearance on 1987-01-12, under 510(k) number K863410.

Who is the listed applicant for PATIENT VALVE WITH AIR ENTRAINMENT?

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

What is the FDA product code for PATIENT VALVE WITH AIR ENTRAINMENT?

The FDA product code for PATIENT VALVE WITH AIR ENTRAINMENT is BTL.

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Other records listing Pneupac , Ltd. 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.

K040090COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)K030803PARAPAC 200D TRANSPORT, MODEL V200DK021841COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGERK020899PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200DK960515PARAPACK862830MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR

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Related Devices (Code: BTL)

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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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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