BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
FDA 510(k) clearance K011471 · decided 2002-11-08
Clearance details
- K-number
- K011471
- Device name
- BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
- Applicant
- Medtronic Functional Diagnostics A/S
- Decision
- Substantially Equivalent
- Date received
- 2001-05-14
- Decision date
- 2002-11-08
- Days to decision
- 543 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Skovlunde, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.