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FDA 510(k)

ANESTHESIA BREATHING BAG, VARIOUS SIZES

K-Number: K822116 · 1982-08-16

ApplicantLife Design Systems, Inc.
Decision Date1982-08-16
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANESTHESIA BREATHING BAG, VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822116. 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 ANESTHESIA BREATHING BAG, VARIOUS SIZES?

ANESTHESIA BREATHING BAG, VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K822116.

When did ANESTHESIA BREATHING BAG, VARIOUS SIZES receive FDA 510(k) clearance?

ANESTHESIA BREATHING BAG, VARIOUS SIZES received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822116.

Who is the listed applicant for ANESTHESIA BREATHING BAG, VARIOUS SIZES?

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

What is the FDA product code for ANESTHESIA BREATHING BAG, VARIOUS SIZES?

The FDA product code for ANESTHESIA BREATHING BAG, VARIOUS SIZES is BTC.

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Other records listing Life Design Systems, Inc. as applicant

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K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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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 ProductsK932584BREATHING BAGSMerit Medical Systems, Inc.K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., 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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