MIDA ALGORITHM REV. B
FDA 510(k) clearance K023414 · decided 2003-12-05
Clearance details
- K-number
- K023414
- Device name
- MIDA ALGORITHM REV. B
- Applicant
- Ortivus AB
- Decision
- Substantially Equivalent
- Date received
- 2002-10-11
- Decision date
- 2003-12-05
- Days to decision
- 420 days
- Clearance type
- Traditional
- Product code
- DYC
- Device class
- 2
- Regulation number
- 870.2400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Taby, SE
- 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 |
|---|---|---|
| MIDA SYSTEM, MODELS 1000/1100 (K896396) | Medical Graphics Corp. | 1990-01-18 |
| CARIEL F12 (K823934) | Odam | 1983-12-16 |
| DIRECT WRITING VECTORCARDIOGRAPH (K810529) | Elmed, Inc. | 1981-04-23 |
Recalls involving this device
No recalls on record reference this clearance.