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FDA 510(k)

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050

K-Number: K950392 · 1995-02-21

ApplicantCal West Trading Co.
Decision Date1995-02-21
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 is the device name listed in this FDA 510(k) record. The listed applicant is Cal West Trading Co.. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K950392. 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 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050?

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Cal West Trading Co.. The 510(k) number is K950392.

When did 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 receive FDA 510(k) clearance?

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 received FDA 510(k) clearance on 1995-02-21, under 510(k) number K950392.

Who is the listed applicant for 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050?

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

What is the FDA product code for 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050?

The FDA product code for 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 is CBP.

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Other records listing Cal West Trading Co. 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.

K933756MAGNASHIELD CPR MOUTH BARRIERK920269EZ GAUZE SPONGEK914842GAUZE BANDAGE ROLLK912952BANDAGE COMPRESSK912950COMPRESS DRESSINGK912953GAUZE COMPRESS

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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.

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