FDA 510(k)

AUTOSTREAKER

K-Number: K771569 · 1977-10-25

ApplicantTomtec

Decision Date1977-10-25

Product Code

DecisionSubstantially Equivalent

Device Summary

AUTOSTREAKER is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec. It received FDA 510(k) clearance on 1977-10-25 under 510(k) number K771569. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSTREAKER?

AUTOSTREAKER is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Tomtec. The 510(k) number is K771569.

When did AUTOSTREAKER receive FDA 510(k) clearance?

AUTOSTREAKER received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771569.

Who is the listed applicant for AUTOSTREAKER?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tomtec as applicant

K811697GUAMSTAINER

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.