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)

CPR MICROSHIELD II

K-Number: K950770 · 1995-03-10

ApplicantPlasco, Inc.
Decision Date1995-03-10
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPR MICROSHIELD II is the device name listed in this FDA 510(k) record. The listed applicant is Plasco, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K950770. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPR MICROSHIELD II?

CPR MICROSHIELD II is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Plasco, Inc.. The 510(k) number is K950770.

When did CPR MICROSHIELD II receive FDA 510(k) clearance?

CPR MICROSHIELD II received FDA 510(k) clearance on 1995-03-10, under 510(k) number K950770.

Who is the listed applicant for CPR MICROSHIELD II?

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

What is the FDA product code for CPR MICROSHIELD II?

The FDA product code for CPR MICROSHIELD II is CBP.

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 Plasco, 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.

K980066CPR FILTERSHIELDK953414CPR MICROMASK WITH OXYGEN INLETK951483CPR MICROMASKK950769CPR MICROMASK PLUS CATALOG NO 73-402K943386CPR MICROMASKK932649PHARMAFEED

View all 16 devices →

Related Devices (Code: CBP)

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.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd.

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.

↑