PREP-CHECK
FDA 510(k) clearance K830876 · decided 1983-05-18
Clearance details
- K-number
- K830876
- Device name
- PREP-CHECK
- Applicant
- General Devices
- Decision
- Substantially Equivalent
- Date received
- 1983-03-18
- Decision date
- 1983-05-18
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- KRC
- Device class
- 2
- Regulation number
- 870.2370
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bergenfield, NJ, 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 |
|---|---|---|
| SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (K023713) | Sontra Medical, Inc. | 2004-01-28 |
| BIOMA 3500 (K872370) | E.B.S., Inc. | 1987-12-07 |
| CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (K874155) | Circadian, Inc. | 1987-11-23 |
| SKIN PREP ANALYZER (K874327) | Marquette Electronics, Inc. | 1987-11-23 |
| IMPEDANCE/8200 MONITOR-MODEL 8300 (K840358) | Aequitron Medical, Inc. | 1984-10-30 |
| CONDUCTANCE METER (K833619) | Circadian, Inc. | 1984-01-27 |
| Z VIEW METER MODEL 300 (K830823) | Lintronics Industries, Inc. | 1983-05-18 |
| GERARD MEDICAL ELECTRODE TESTER (K813358) | Gerard Medical Enterprises, Inc. | 1981-12-29 |
| ELECTRODE TESTER (K780501) | Mg Medical Electronics | 1978-05-19 |
| TS-100 TEST SYSTEM (K771014) | Delta Medical Industries | 1977-06-14 |
Recalls involving this device
No recalls on record reference this clearance.