NF DEVICE
FDA 510(k) clearance K770517 · decided 1977-07-15
Clearance details
- K-number
- K770517
- Device name
- NF DEVICE
- Applicant
- Rpr, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-18
- Decision date
- 1977-07-15
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- KPD
- Device class
- 2
- Regulation number
- 880.2200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| E-Z TEMP II (K934941) | Seven C'S, Inc. | 1994-07-27 |
| TEMP MARQ TEMPERATURE TREND INDICATOR (K903307) | Marquest Medical Products, Inc. | 1990-08-17 |
| FEVER LINE AND FEVER LINE PLUS (K893803) | Liquid Crystal Sciences, Inc. | 1989-08-21 |
| OMNI THERM TEMPERATURE MONITOR (K864853) | Omni Therm, Inc. | 1987-02-04 |
| TEMPALERT LIQUID CRYSTAL THERMOMETER (K850797) | Medical Frontiers, Inc. | 1985-04-05 |
| TEMPTREND PEDS AXILLARY TEMP. INDICATOR (K841913) | Biosynergy, Inc. | 1984-11-02 |
| TEMPTREND II (K833904) | Biosynergy, Inc. | 1983-12-27 |
| ATI FOREHEAD THERMOMETER (K832651) | American Thermal Instruments, Inc. | 1983-10-04 |
| ACCA-TEMP SKIN TEMP. VINYL DISC (K823221) | T. G. & E. Medical | 1983-01-12 |
| TEMPTREND TEMPERATURE TREND INDICATOR (K821312) | Liquid Crystal Products, Inc. | 1982-05-28 |
| TEMPERATURE TREND INDICATOR (TTI) (K820426) | Mon-A-Therm, Inc. | 1982-03-08 |
| SKIN TEMPERATURE SENSING VINYL STRIP (K813199) | T. G. & E. Medical | 1982-03-05 |
Recalls involving this device
No recalls on record reference this clearance.