Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MICRO SPIROMETER

K-Number: K963035 · 1996-11-01

ApplicantMicro Direct, Inc.
Decision Date1996-11-01
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICRO SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Micro Direct, Inc.. It received FDA 510(k) clearance on 1996-11-01 under 510(k) number K963035. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO SPIROMETER?

MICRO SPIROMETER is a medical device that received FDA 510(k) clearance on 1996-11-01. The listed applicant is Micro Direct, Inc.. The 510(k) number is K963035.

When did MICRO SPIROMETER receive FDA 510(k) clearance?

MICRO SPIROMETER received FDA 510(k) clearance on 1996-11-01, under 510(k) number K963035.

Who is the listed applicant for MICRO SPIROMETER?

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

What is the FDA product code for MICRO SPIROMETER?

The FDA product code for MICRO SPIROMETER is BZG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Micro Direct, 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.

K033688MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYK031102MICROLAB SPIROMETERK030586MICROPEAKK973314SPIROSAFE FILTERK965042MICRODL DIARYCARD SPIROMETERK963376MICRO H2

View all 9 devices →

Related Devices (Code: BZG)

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.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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.

↑