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)

REBREATHER BAGS

K-Number: K940220 · 1994-05-27

ApplicantZefon Medical Products
Decision Date1994-05-27
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REBREATHER BAGS is the device name listed in this FDA 510(k) record. The listed applicant is Zefon Medical Products. It received FDA 510(k) clearance on 1994-05-27 under 510(k) number K940220. 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 REBREATHER BAGS?

REBREATHER BAGS is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Zefon Medical Products. The 510(k) number is K940220.

When did REBREATHER BAGS receive FDA 510(k) clearance?

REBREATHER BAGS received FDA 510(k) clearance on 1994-05-27, under 510(k) number K940220.

Who is the listed applicant for REBREATHER BAGS?

The FDA 510(k) record lists Zefon Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REBREATHER BAGS?

The FDA product code for REBREATHER BAGS 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 Zefon Medical Products 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.

K934462ADULT ANESTHESIA BREATHING CIRCUIT KITSK930957ZEFON GAS SAMPLING LINESK924889ZEFON ADULT ANESTHESIA BREATHING CIRCUIT

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, LLCK932584BREATHING BAGSMerit Medical Systems, Inc.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932191BREATHING BAGSLife Shield Healthcare Products, Inc.K894906ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITERMed-Tek Corp.

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.

↑