FDA 510(k)

ERIE-NEB

K-Number: K861865 · 1986-07-01

Decision Date1986-07-01

Product CodeBTI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ERIE-NEB is the device name listed in this FDA 510(k) record. The listed applicant is Erie Medical. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K861865. 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 ERIE-NEB?

ERIE-NEB is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Erie Medical. The 510(k) number is K861865.

When did ERIE-NEB receive FDA 510(k) clearance?

ERIE-NEB received FDA 510(k) clearance on 1986-07-01, under 510(k) number K861865.

Who is the listed applicant for ERIE-NEB?

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

What is the FDA product code for ERIE-NEB?

The FDA product code for ERIE-NEB is BTI.

Other records listing Erie Medical 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.

K853051TRACHEAL TUBES K853039PRESSURE REGULATOR K853040PRESSURE GAUGE K832466TRACHEAL TUBE 16 GAUGE-1.65MM-

Related Devices (Code: BTI)

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.