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FDA 510(k)

MEDTECH C.P.R. MASK

K-Number: K862199 · 1986-06-13

ApplicantThe Medtech Group, Inc.
Decision Date1986-06-13
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDTECH C.P.R. MASK is the device name listed in this FDA 510(k) record. The listed applicant is The Medtech Group, Inc.. It received FDA 510(k) clearance on 1986-06-13 under 510(k) number K862199. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTECH C.P.R. MASK?

MEDTECH C.P.R. MASK is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is The Medtech Group, Inc.. The 510(k) number is K862199.

When did MEDTECH C.P.R. MASK receive FDA 510(k) clearance?

MEDTECH C.P.R. MASK received FDA 510(k) clearance on 1986-06-13, under 510(k) number K862199.

Who is the listed applicant for MEDTECH C.P.R. MASK?

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

What is the FDA product code for MEDTECH C.P.R. MASK?

The FDA product code for MEDTECH C.P.R. MASK is CAE.

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 The Medtech Group, 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.

K895203EN-TRAP SYRINGE

Related Devices (Code: CAE)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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