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FDA 510(k)

MEDICAL/SURGICAL SUCTION SYSTEM

K-Number: K851384 · 1985-05-08

ApplicantPuritan Bennett Corp.
Decision Date1985-05-08
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICAL/SURGICAL SUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1985-05-08 under 510(k) number K851384. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL/SURGICAL SUCTION SYSTEM?

MEDICAL/SURGICAL SUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-05-08. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K851384.

When did MEDICAL/SURGICAL SUCTION SYSTEM receive FDA 510(k) clearance?

MEDICAL/SURGICAL SUCTION SYSTEM received FDA 510(k) clearance on 1985-05-08, under 510(k) number K851384.

Who is the listed applicant for MEDICAL/SURGICAL SUCTION SYSTEM?

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

What is the FDA product code for MEDICAL/SURGICAL SUCTION SYSTEM?

The FDA product code for MEDICAL/SURGICAL SUCTION SYSTEM is GCX.

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Other records listing Puritan Bennett 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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