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)

ADIDYNE 3000

K-Number: K771707 · 1977-09-26

ApplicantTimeter Instrument Corp.
Decision Date1977-09-26
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ADIDYNE 3000 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 1977-09-26 under 510(k) number K771707. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADIDYNE 3000?

ADIDYNE 3000 is a medical device that received FDA 510(k) clearance on 1977-09-26. The listed applicant is Timeter Instrument Corp.. The 510(k) number is K771707.

When did ADIDYNE 3000 receive FDA 510(k) clearance?

ADIDYNE 3000 received FDA 510(k) clearance on 1977-09-26, under 510(k) number K771707.

Who is the listed applicant for ADIDYNE 3000?

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 ADIDYNE 3000?

The FDA product code for ADIDYNE 3000 is BTI.

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: BTI)

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.

K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.K113338MEDICAL AIR COMPRESSOROricare, Inc.K091871DK50 DSEkom S.R.O.K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.K051691MINIMATE COMPRESSORPrecision Medical, 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.

↑