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FDA 510(k)

KING SYSTEMS, BREATHING BAG

K-Number: K880680 · 1988-03-03

ApplicantKing Systems Corp.
Decision Date1988-03-03
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KING SYSTEMS, BREATHING BAG is the device name listed in this FDA 510(k) record. The listed applicant is King Systems Corp.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K880680. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING SYSTEMS, BREATHING BAG?

KING SYSTEMS, BREATHING BAG is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is King Systems Corp.. The 510(k) number is K880680.

When did KING SYSTEMS, BREATHING BAG receive FDA 510(k) clearance?

KING SYSTEMS, BREATHING BAG received FDA 510(k) clearance on 1988-03-03, under 510(k) number K880680.

Who is the listed applicant for KING SYSTEMS, BREATHING BAG?

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

What is the FDA product code for KING SYSTEMS, BREATHING BAG?

The FDA product code for KING SYSTEMS, BREATHING BAG is BTC.

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 King Systems Corp. 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.

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105K012485MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCEK010040SLEEVED FILTERK990614HME-BOOSTER

View all 18 devices →

Related Devices (Code: BTC)

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.

K181424PeDIAPedia, LLCK940220REBREATHER BAGSZefon Medical ProductsK932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932584BREATHING BAGSMerit Medical Systems, Inc.K932191BREATHING BAGSLife Shield Healthcare Products, Inc.

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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