SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
FDA 510(k) clearance K011729 · decided 2001-08-30
Clearance details
- K-number
- K011729
- Device name
- SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
- Applicant
- Dni Nevada, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-04
- Decision date
- 2001-08-30
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DTC
- Device class
- 2
- Regulation number
- 870.3630
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Carson City, NV, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| PSA Cable (K170815) | Boston Scientific Corporation | 2017-07-06 |
| PK-141 PATIENT CABLE (K083674) | Biotronik, Inc. | 2009-04-01 |
| MODEL 4810 ANALYZER OUTPUT ADAPTER (K002497) | Pace Medical | 2000-10-10 |
| EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (K961582) | North American Technical Services Corp. | 1996-11-08 |
| EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (K903966) | Bio-Tek Instruments, Inc. | 1991-06-19 |
| MODEL 5311B A-V PACING SYSTEM ANALYZER (K910595) | Medtronic Vascular | 1991-05-07 |
| CPI MODEL 2215/SEAMED MODEL 3400 (K910223) | Seamed Corp. | 1991-03-19 |
| PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (K901332) | Biotronik, GmbH & Co. | 1990-05-09 |
| MEDTRONIC MODEL 5401B TEST CABLE (K896632) | Medtronic Vascular | 1989-12-13 |
| MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (K884331) | Medtronic Vascular | 1989-01-10 |
| PACER SENSING ANALYZER (PSA 100) (K882327) | Oscor Medical Corp. | 1988-10-06 |
| SEAMED MODEL 3000 (K860462) | Seamed Corp. | 1986-08-19 |
Recalls involving this device
No recalls on record reference this clearance.