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FDA 510(k)

O2 CARE

K-Number: K882461 · 1988-11-28

ApplicantBallard Medical Products
Decision Date1988-11-28
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

O2 CARE 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 1988-11-28 under 510(k) number K882461. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the O2 CARE?

O2 CARE is a medical device that received FDA 510(k) clearance on 1988-11-28. The listed applicant is Ballard Medical Products. The 510(k) number is K882461.

When did O2 CARE receive FDA 510(k) clearance?

O2 CARE received FDA 510(k) clearance on 1988-11-28, under 510(k) number K882461.

Who is the listed applicant for O2 CARE?

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 O2 CARE?

The FDA product code for O2 CARE is KPJ.

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: KPJ)

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.

K250188Wound Treatment System (VHT-200)Vaporox, Inc.K212121VHT-200 Wound Treatment SystemVaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba OgenixK112634NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.K120764EPIFLO(R)Neogenix, LLCK090681TANSCU O2Electrochemical Oxygen Concepts, 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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