VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
FDA 510(k) clearance K803309 · decided 1981-01-16
Clearance details
- K-number
- K803309
- Device name
- VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
- Applicant
- Advanced Technology Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-30
- Decision date
- 1981-01-16
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DPS
- Device class
- 2
- Regulation number
- 870.2340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD (P940005/S002) | Advanced Technology Laboratories, Inc. | 1998-07-21 |
| HDI 3000 ULTRASOUND SYSTEM (P940005/S001) | Advanced Technology Laboratories, Inc. | 1996-12-23 |
| ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM (P940005) | Advanced Technology Laboratories, Inc. | 1996-04-11 |