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FDA 510(k)

PRONEB ULTRA MODEL NUMBER 85B0100

K-Number: K002862 · 2001-03-13

ApplicantPari Holding Co.
Decision Date2001-03-13
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRONEB ULTRA MODEL NUMBER 85B0100 is the device name listed in this FDA 510(k) record. The listed applicant is Pari Holding Co.. It received FDA 510(k) clearance on 2001-03-13 under 510(k) number K002862. 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 PRONEB ULTRA MODEL NUMBER 85B0100?

PRONEB ULTRA MODEL NUMBER 85B0100 is a medical device that received FDA 510(k) clearance on 2001-03-13. The listed applicant is Pari Holding Co.. The 510(k) number is K002862.

When did PRONEB ULTRA MODEL NUMBER 85B0100 receive FDA 510(k) clearance?

PRONEB ULTRA MODEL NUMBER 85B0100 received FDA 510(k) clearance on 2001-03-13, under 510(k) number K002862.

Who is the listed applicant for PRONEB ULTRA MODEL NUMBER 85B0100?

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

What is the FDA product code for PRONEB ULTRA MODEL NUMBER 85B0100?

The FDA product code for PRONEB ULTRA MODEL NUMBER 85B0100 is BTI.

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Other records listing Pari Holding Co. 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.

K983308RC CORNET, MODEL #44F50K972042PARI PEP THERAPY SYSTEMK963924LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70K962072PRONEB TURBO COMPRESSOR MODEL 38V0200K960675WALKHALER PORTABLE COMPRESSOR MODEL 45F70K935540PARI-MASTER MODIFICATION

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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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