RATE PROGRAMMER MODEL 520
FDA 510(k) clearance K780175 · decided 1978-04-21
Clearance details
- K-number
- K780175
- Device name
- RATE PROGRAMMER MODEL 520
- Applicant
- Intermedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-03
- Decision date
- 1978-04-21
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KRG
- Device class
- 3
- Regulation number
- 870.3700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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 |
|---|---|---|
| INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (K933278) | Intermedics, Inc. | 1995-03-15 |
| MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (K884522) | Teletronics, Inc. | 1989-08-25 |
| MODEL 2331T PATIENT PROGRAMMER (K880738) | Medtronic Vascular | 1988-11-17 |
| MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (K882429) | Tpl-Cordis, Inc. | 1988-07-22 |
| MODEL 1740 PERSONAL POCKET PROGRAMMER (K864712) | Telectronics, Inc. | 1987-12-17 |
| MODEL 5600B PROGRAMMER, PACEMAKER (K871986) | Telectronics, Inc. | 1987-06-24 |
| ULTRA SOFTWARE MODULE: MODEL 2016 (K863046) | Cardiac Pacemakers, Inc. | 1986-12-05 |
| PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (K863045) | Cardiac Pacemakers, Inc. | 1986-09-29 |
| SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (K860584) | Cardiac Pacemakers, Inc. | 1986-06-06 |
| DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546) | Pacesetter Systems | 1986-04-23 |
| HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (K844484) | Vitatron Medical BV | 1985-07-24 |
| CERYX6, 611, CERYX 3 311 & CERYX 1 111 (K844485) | Vitatron Medical BV | 1985-04-19 |
Recalls involving this device
No recalls on record reference this clearance.