BETTER-BLADDER (BB)— 510(k) K964337
Substantially EquivalentCirculatory Technology, Inc.
FDA 510(k) clearance K964337 for BETTER-BLADDER (BB), Substantially Equivalent on 1997-05-23. Applicant: Circulatory Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Circulatory Technology, Inc.
- Product code
- Code FIB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oyster Bay, NY, US
Recent devices under product code FIB
view all- K240164 — NovaLine SP-C35 Transducer Protector (956007)
- K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
- K001971 — HEMODIALYSIS TUBING SETS
- K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
More clearances from Circulatory Technology, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.