PROTIME MICROCOAGULATION SYSTEM
FDA 510(k) clearance K951072 · decided 1995-10-27
Clearance details
- K-number
- K951072
- Device name
- PROTIME MICROCOAGULATION SYSTEM
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-08
- Decision date
- 1995-10-27
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- GKP
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch International Technidyne Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Tec recall (Z-0548-2008) | International Technidyne Corporation | 2008-01-25 |
| International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Cata recall (Z-0470-2007) | International Technidyne Corp. | 2007-01-13 |