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FDA 510(k)

C.P.A.P. VALVE AND C.P.P.A. KIT

K-Number: K895360 · 1989-11-15

ApplicantBallard Medical Products
Decision Date1989-11-15
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

C.P.A.P. VALVE AND C.P.P.A. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1989-11-15 under 510(k) number K895360. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C.P.A.P. VALVE AND C.P.P.A. KIT?

C.P.A.P. VALVE AND C.P.P.A. KIT is a medical device that received FDA 510(k) clearance on 1989-11-15. The listed applicant is Ballard Medical Products. The 510(k) number is K895360.

When did C.P.A.P. VALVE AND C.P.P.A. KIT receive FDA 510(k) clearance?

C.P.A.P. VALVE AND C.P.P.A. KIT received FDA 510(k) clearance on 1989-11-15, under 510(k) number K895360.

Who is the listed applicant for C.P.A.P. VALVE AND C.P.P.A. KIT?

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

What is the FDA product code for C.P.A.P. VALVE AND C.P.P.A. KIT?

The FDA product code for C.P.A.P. VALVE AND C.P.P.A. KIT is BYE.

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Other records listing Ballard 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.

K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEK022398REUSABLE BRONCHIAL BIOPSY FORCEPSK013892LUTZ NEEDLEK000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESK993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITK990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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