MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
FDA 510(k) clearance K992305 · decided 1999-09-08
Clearance details
- K-number
- K992305
- Device name
- MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
- Applicant
- Medi-Stim A/S
- Decision
- Substantially Equivalent
- Date received
- 1999-07-08
- Decision date
- 1999-09-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Oslo, NO
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.