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FDA 510(k)

PENLON CIRCLE SYSTEM

K-Number: K864588 · 1987-02-03

ApplicantBear Medical Systems, Inc.
Decision Date1987-02-03
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PENLON CIRCLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bear Medical Systems, Inc.. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K864588. 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 PENLON CIRCLE SYSTEM?

PENLON CIRCLE SYSTEM is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K864588.

When did PENLON CIRCLE SYSTEM receive FDA 510(k) clearance?

PENLON CIRCLE SYSTEM received FDA 510(k) clearance on 1987-02-03, under 510(k) number K864588.

Who is the listed applicant for PENLON CIRCLE SYSTEM?

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

What is the FDA product code for PENLON CIRCLE SYSTEM?

The FDA product code for PENLON CIRCLE SYSTEM is CAI.

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Other records listing Bear Medical 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.

K992788BEAR CUB 750 PSVK983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBEK912619BEAR 7 VENTILATORK900637BEAR CEM CONTROLLERK896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLYK893034VHS 820 HUMIDIFIER, MODIFICATION

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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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