Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004
FDA 510(k) K992305 · Medi-Stim A/S
510(k) numberK992305
Submission
- Device name
- Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004
- Applicant
- Medi-Stim A/S
Oslo, NO - Received
- July 8, 1999
- Decision date
- September 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004 cleared by the FDA?
Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004 (K992305) received a 510(k) decision of Substantially Equivalent on September 8, 1999, 62 days after the submission was received.
What is the product code of K992305?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.