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FDA 510(k)

POSITIVE CLOSURE ANESTHETIC VALVE

K-Number: K811015 · 1981-05-15

ApplicantOrthopedic Systems, Inc.
Decision Date1981-05-15
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POSITIVE CLOSURE ANESTHETIC VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1981-05-15 under 510(k) number K811015. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POSITIVE CLOSURE ANESTHETIC VALVE?

POSITIVE CLOSURE ANESTHETIC VALVE is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K811015.

When did POSITIVE CLOSURE ANESTHETIC VALVE receive FDA 510(k) clearance?

POSITIVE CLOSURE ANESTHETIC VALVE received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811015.

Who is the listed applicant for POSITIVE CLOSURE ANESTHETIC VALVE?

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

What is the FDA product code for POSITIVE CLOSURE ANESTHETIC VALVE?

The FDA product code for POSITIVE CLOSURE ANESTHETIC VALVE is CAI.

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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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