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FDA 510(k)

FLOSENSE, MODEL 29-8010

K-Number: K990962 · 2000-01-07

ApplicantSdi Diagnostics, Inc.
Decision Date2000-01-07
Product CodeJAX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOSENSE, MODEL 29-8010 is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-01-07 under 510(k) number K990962. The device is classified under product code JAX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOSENSE, MODEL 29-8010?

FLOSENSE, MODEL 29-8010 is a medical device that received FDA 510(k) clearance on 2000-01-07. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K990962.

When did FLOSENSE, MODEL 29-8010 receive FDA 510(k) clearance?

FLOSENSE, MODEL 29-8010 received FDA 510(k) clearance on 2000-01-07, under 510(k) number K990962.

Who is the listed applicant for FLOSENSE, MODEL 29-8010?

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

What is the FDA product code for FLOSENSE, MODEL 29-8010?

The FDA product code for FLOSENSE, MODEL 29-8010 is JAX.

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Other records listing Sdi Diagnostics, 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.

K150515IQSense Flow Sensor MouthpieceK092813ASTRASONIC SPIROMETER, MODEL 29-8000K061571ASTRA 300K062913ASTRAGUARD PULMONARY FUNCTION FILTERK033939FLOSENSE II, MODEL 29-8040K031643SPIROTEL, MODEL 29-1020

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Related Devices (Code: JAX)

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.

K921178PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHSMedical Associated Services, Inc.K884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORSpirometrics, Inc.K853085PAX METERPeace Medical, Inc.K833265RESPIRATORY FLOW MODULEThoratec Laboratories Corp.K812825FLO-COR IBiotrine Corp.K791730RING-ORIFICE, TURBULENT FLOW PNEUMOTResearch Development 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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