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)

SPIROMETEO EXHAUST

K-Number: K770907 · 1977-07-05

ApplicantTimeter Instrument Corp.
Decision Date1977-07-05
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETEO EXHAUST is the device name listed in this FDA 510(k) record. The listed applicant is Timeter Instrument Corp.. It received FDA 510(k) clearance on 1977-07-05 under 510(k) number K770907. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETEO EXHAUST?

SPIROMETEO EXHAUST is a medical device that received FDA 510(k) clearance on 1977-07-05. The listed applicant is Timeter Instrument Corp.. The 510(k) number is K770907.

When did SPIROMETEO EXHAUST receive FDA 510(k) clearance?

SPIROMETEO EXHAUST received FDA 510(k) clearance on 1977-07-05, under 510(k) number K770907.

Who is the listed applicant for SPIROMETEO EXHAUST?

The FDA 510(k) record lists Timeter Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIROMETEO EXHAUST?

The FDA product code for SPIROMETEO EXHAUST is BZK.

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 Timeter Instrument Corp. 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.

K875075RT-200 COMPUTER INTERFACEK875074VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000K871603CRITERION II & IIA OXYGEN CONCENTRATORSK864836L.A.P. SPIROMETERK834274CRITERION IK823775BORDON GAGE REGULATOR #BG

View all 29 devices →

Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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.

↑