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FDA 510(k)

BIG BAG 3000 PRESSURE INFUSOR

K-Number: K973133 · 1997-09-12

ApplicantByron Medical
Decision Date1997-09-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

BIG BAG 3000 PRESSURE INFUSOR is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1997-09-12 under 510(k) number K973133. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the BIG BAG 3000 PRESSURE INFUSOR?

BIG BAG 3000 PRESSURE INFUSOR is a medical device that received FDA 510(k) clearance on 1997-09-12. The listed applicant is Byron Medical. The 510(k) number is K973133.

When did BIG BAG 3000 PRESSURE INFUSOR receive FDA 510(k) clearance?

BIG BAG 3000 PRESSURE INFUSOR received FDA 510(k) clearance on 1997-09-12, under 510(k) number K973133.

Who is the listed applicant for BIG BAG 3000 PRESSURE INFUSOR?

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

What is the FDA product code for BIG BAG 3000 PRESSURE INFUSOR?

The FDA product code for BIG BAG 3000 PRESSURE INFUSOR is FRN.

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Other records listing Byron 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

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Related Devices (Code: FRN)

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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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