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FDA 510(k)

SPIROMETRICS MODEL 2500 FLOWMATE(TM)

K-Number: K863953 · 1987-01-15

ApplicantSpirometrics, Inc.
Decision Date1987-01-15
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETRICS MODEL 2500 FLOWMATE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics, Inc.. It received FDA 510(k) clearance on 1987-01-15 under 510(k) number K863953. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETRICS MODEL 2500 FLOWMATE(TM)?

SPIROMETRICS MODEL 2500 FLOWMATE(TM) is a medical device that received FDA 510(k) clearance on 1987-01-15. The listed applicant is Spirometrics, Inc.. The 510(k) number is K863953.

When did SPIROMETRICS MODEL 2500 FLOWMATE(TM) receive FDA 510(k) clearance?

SPIROMETRICS MODEL 2500 FLOWMATE(TM) received FDA 510(k) clearance on 1987-01-15, under 510(k) number K863953.

Who is the listed applicant for SPIROMETRICS MODEL 2500 FLOWMATE(TM)?

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

What is the FDA product code for SPIROMETRICS MODEL 2500 FLOWMATE(TM)?

The FDA product code for SPIROMETRICS MODEL 2500 FLOWMATE(TM) is BZM.

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Other records listing Spirometrics, Inc. 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.

K915059PEAK FLOW MONITORK911358CMD/DLCO DIAGNOSTIC SPIROMETERK900322CO/CMD-1K901057SPIROMETRICS MODEL 2600 MIRO SPIROMETERK900673SERIAL FLOWK884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

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Related Devices (Code: BZM)

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.

K102229PULMOTRACK 2020 SYSTEMKarmelsonixK090863PERSONAL WHEEZOMETERKarmelsonixK071955WIM-PC, MODEL 1010KarmelsonixK012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.K980878PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.

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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