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FDA 510(k)

MOBIL 02

K-Number: K864680 · 1987-01-09

ApplicantRoman Laboratories, Inc.
Decision Date1987-01-09
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOBIL 02 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 1987-01-09 under 510(k) number K864680. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBIL 02?

MOBIL 02 is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Roman Laboratories, Inc.. The 510(k) number is K864680.

When did MOBIL 02 receive FDA 510(k) clearance?

MOBIL 02 received FDA 510(k) clearance on 1987-01-09, under 510(k) number K864680.

Who is the listed applicant for MOBIL 02?

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 02?

The FDA product code for MOBIL 02 is BTI.

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.

K870064MOBIL-AIR

Related Devices (Code: BTI)

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.

K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.K113338MEDICAL AIR COMPRESSOROricare, Inc.K091871DK50 DSEkom S.R.O.K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.K051691MINIMATE COMPRESSORPrecision Medical, Inc.

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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