HEMOCLEAN
FDA 510(k) clearance K023064 · decided 2004-04-06
Clearance details
- K-number
- K023064
- Device name
- HEMOCLEAN
- Applicant
- Krd Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-16
- Decision date
- 2004-04-06
- Days to decision
- 568 days
- Clearance type
- Traditional
- Product code
- NII
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OZONE GENERATOR (K043207) | Ge Infrastructure Water & Process Technologies | 2005-11-04 |
Recalls involving this device
No recalls on record reference this clearance.