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FDA 510(k)

PORTA-NEB(R) 310

K-Number: K801286 · 1980-07-08

ApplicantE.B.E. Research & Mfg., Inc.
Decision Date1980-07-08
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTA-NEB(R) 310 is the device name listed in this FDA 510(k) record. The listed applicant is E.B.E. Research & Mfg., Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801286. 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 PORTA-NEB(R) 310?

PORTA-NEB(R) 310 is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is E.B.E. Research & Mfg., Inc.. The 510(k) number is K801286.

When did PORTA-NEB(R) 310 receive FDA 510(k) clearance?

PORTA-NEB(R) 310 received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801286.

Who is the listed applicant for PORTA-NEB(R) 310?

The FDA 510(k) record lists E.B.E. Research & Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA-NEB(R) 310?

The FDA product code for PORTA-NEB(R) 310 is BTI.

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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

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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