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FDA 510(k)

DISPOSABLE INCENTIVE SPIROMETER

K-Number: K781394 · 1978-10-16

ApplicantInhal-O-Tech Medical Plastic
Decision Date1978-10-16
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Inhal-O-Tech Medical Plastic. It received FDA 510(k) clearance on 1978-10-16 under 510(k) number K781394. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE INCENTIVE SPIROMETER?

DISPOSABLE INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 1978-10-16. The listed applicant is Inhal-O-Tech Medical Plastic. The 510(k) number is K781394.

When did DISPOSABLE INCENTIVE SPIROMETER receive FDA 510(k) clearance?

DISPOSABLE INCENTIVE SPIROMETER received FDA 510(k) clearance on 1978-10-16, under 510(k) number K781394.

Who is the listed applicant for DISPOSABLE INCENTIVE SPIROMETER?

The FDA 510(k) record lists Inhal-O-Tech Medical Plastic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE INCENTIVE SPIROMETER?

The FDA product code for DISPOSABLE INCENTIVE SPIROMETER is CCQ.

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Other records listing Inhal-O-Tech Medical Plastic 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.

K781741MASK, BI FLO NASAL OXYGENK781395DISPOSABLE AEROSOL T BRIGGS ADAPTORK770354TUBING, AEROSAL, DISPOSABLEK770353DISPOSABLE TEMPERATURE PROBEK760329MASK, DISPOSABLE OXYGEN THERAPYK760330CANNULA, DISPOSABLE OXYGEN TTHERAPY

View all 7 devices →

Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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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