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FDA 510(k)

MOBILE PAK, MODEL AC

K-Number: K880261 · 1988-02-12

ApplicantIntl. Biomedical Concepts, Inc.
Decision Date1988-02-12
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOBILE PAK, MODEL AC is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Biomedical Concepts, Inc.. It received FDA 510(k) clearance on 1988-02-12 under 510(k) number K880261. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILE PAK, MODEL AC?

MOBILE PAK, MODEL AC is a medical device that received FDA 510(k) clearance on 1988-02-12. The listed applicant is Intl. Biomedical Concepts, Inc.. The 510(k) number is K880261.

When did MOBILE PAK, MODEL AC receive FDA 510(k) clearance?

MOBILE PAK, MODEL AC received FDA 510(k) clearance on 1988-02-12, under 510(k) number K880261.

Who is the listed applicant for MOBILE PAK, MODEL AC?

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

What is the FDA product code for MOBILE PAK, MODEL AC?

The FDA product code for MOBILE PAK, MODEL AC is CAW.

Related Clinical Trials

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.

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Other records listing Intl. Biomedical Concepts, 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.

K880262MOBILE PAK, MODEL DC

Related Devices (Code: CAW)

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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