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FDA 510(k)

MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004

K-Number: K992305 · 1999-09-08

ApplicantMedi-Stim A/S
Decision Date1999-09-08
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Stim A/S. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K992305. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004?

MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Medi-Stim A/S. The 510(k) number is K992305.

When did MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 receive FDA 510(k) clearance?

MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992305.

Who is the listed applicant for MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004?

The FDA 510(k) record lists Medi-Stim A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004?

The FDA product code for MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 is ITX.

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Other records listing Medi-Stim A/S 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.

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Related Devices (Code: ITX)

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Official Source

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