FDA 510(k)

PASSY-MUIR O2 ADAPTER; PMA2000

K-Number: K970365 · 1997-02-12

Decision Date1997-02-12

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PASSY-MUIR O2 ADAPTER; PMA2000 is the device name listed in this FDA 510(k) record. The listed applicant is Passy-Muir, Inc.. It received FDA 510(k) clearance on 1997-02-12 under 510(k) number K970365. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSY-MUIR O2 ADAPTER; PMA2000?

PASSY-MUIR O2 ADAPTER; PMA2000 is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Passy-Muir, Inc.. The 510(k) number is K970365.

When did PASSY-MUIR O2 ADAPTER; PMA2000 receive FDA 510(k) clearance?

PASSY-MUIR O2 ADAPTER; PMA2000 received FDA 510(k) clearance on 1997-02-12, under 510(k) number K970365.

Who is the listed applicant for PASSY-MUIR O2 ADAPTER; PMA2000?

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

What is the FDA product code for PASSY-MUIR O2 ADAPTER; PMA2000?

The FDA product code for PASSY-MUIR O2 ADAPTER; PMA2000 is JOH.

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Other records listing Passy-Muir, Inc. as applicant

K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)K990905PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT K962714PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 K944451PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)

Related Devices (Code: JOH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.