FDA 510(k)

VITALINE 2

K-Number: K822856 · 1983-07-29

Decision Date1983-07-29

Product Code

DecisionSubstantially Equivalent

Device Summary

VITALINE 2 is the device name listed in this FDA 510(k) record. The listed applicant is American Heartline, Inc.. It received FDA 510(k) clearance on 1983-07-29 under 510(k) number K822856. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALINE 2?

VITALINE 2 is a medical device that received FDA 510(k) clearance on 1983-07-29. The listed applicant is American Heartline, Inc.. The 510(k) number is K822856.

When did VITALINE 2 receive FDA 510(k) clearance?

VITALINE 2 received FDA 510(k) clearance on 1983-07-29, under 510(k) number K822856.

Who is the listed applicant for VITALINE 2?

The FDA 510(k) record lists American Heartline, Inc. 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 American Heartline, Inc. as applicant

K812695DISK

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.