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FDA 510(k)

MOBIL-AIR

K-Number: K870064 · 1987-02-11

ApplicantRoman Laboratories, Inc.
Decision Date1987-02-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOBIL-AIR is the device name listed in this FDA 510(k) record. The listed applicant is Roman Laboratories, Inc.. It received FDA 510(k) clearance on 1987-02-11 under 510(k) number K870064. 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 MOBIL-AIR?

MOBIL-AIR is a medical device that received FDA 510(k) clearance on 1987-02-11. The listed applicant is Roman Laboratories, Inc.. The 510(k) number is K870064.

When did MOBIL-AIR receive FDA 510(k) clearance?

MOBIL-AIR received FDA 510(k) clearance on 1987-02-11, under 510(k) number K870064.

Who is the listed applicant for MOBIL-AIR?

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

What is the FDA product code for MOBIL-AIR?

The FDA product code for MOBIL-AIR 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 Roman Laboratories, 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.

K864680MOBIL 02

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.

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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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