FLEXILOG 2000
FDA 510(k) clearance K945069 · decided 1995-06-13
Clearance details
- K-number
- K945069
- Device name
- FLEXILOG 2000
- Applicant
- Oakfield Instruments, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-14
- Decision date
- 1995-06-13
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- FFT
- Device class
- 1
- Regulation number
- 876.1400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oxon Ox8 1ja England, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Oakfield Instruments
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.
| Record | Firm | Date |
|---|---|---|
| BRAVO PH MONITORING SYSTEM AND ACCESSORIES (K102543) | Given Imaging , Ltd. | 2010-12-01 |
| SANDHILL SCIENTIFIC PEDIATEC PH PROBE (K013951) | Sandhill Scientific, Inc. | 2002-02-28 |
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |
| PH ANALYSIS MODULE (K961346) | Synectics-Dantec | 1997-01-29 |
| LOT 440 (K950087) | Medical Instruments Corporation Mic AG | 1996-02-06 |
| TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (K955018) | Instrumentarium Corp. | 1996-01-30 |
| TRIP CIC CATHETER (K920849) | Tonometrics, Inc. | 1995-03-17 |
| CYBERRX MODEL 7200 (K934434) | Cybermed Control Systems, Inc. | 1995-01-24 |
| ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (K925405) | Synectics-Dantec | 1994-09-30 |
| SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963) | Sandhill Scientific, Inc. | 1994-09-28 |
| MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817) | Synectics-Dantec | 1992-06-11 |
| PH METER, MODIFICATION (K914624) | Synectics-Dantec | 1992-04-28 |
Recalls involving this device
No recalls on record reference this clearance.