PACEMAKER SYS ANALYZER #384
FDA 510(k) clearance K833647 · decided 1983-12-16
Clearance details
- K-number
- K833647
- Device name
- PACEMAKER SYS ANALYZER #384
- Applicant
- Pacesetter Systems
- Decision
- Substantially Equivalent
- Date received
- 1983-10-17
- Decision date
- 1983-12-16
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- KRE
- Device class
- 2
- Regulation number
- 870.3640
- 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 |
|---|---|---|
| PACEART OPTIMA SYSTEM SOFTWARE (K110693) | Medtronic, Inc. | 2011-06-08 |
| CYGNUS 12 LEAD ECG MODULE (K072950) | Cygnus, LLC | 2008-08-22 |
| EKG SPEAKS (K032926) | Medtronic Vascular | 2003-10-15 |
| HPM 40 HEART PACEMAKER MONITOR (K922742) | Biotronik, GmbH & Co. | 1993-03-18 |
| PACEART CPTS-86/12 (K915632) | Paceart, Inc. | 1992-04-14 |
| PACEVIEW (K895535) | Micromedical | 1990-03-19 |
| PACEMAKER FUNCTION ANALYZER (K870909) | Paceart, Inc. | 1987-04-27 |
| PACEMAKER SYS. ANALYZER 378 (K832959) | Siemens Elema AB | 1983-11-14 |
| CARDIOMEMO (K803286) | Instromedix, Inc. | 1981-03-17 |
| ELECTRONIC PACEMAKER WAVEFORM ANALYZER (K800696) | Instromedix, Inc. | 1980-08-14 |
| ULTRA-CHEK PACEMAKER MONITOR (K801022) | Powers Medical Systmes | 1980-06-17 |
| PACE-PULSE/COMPUTRAC (K800782) | Bib, Inc. | 1980-05-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CARBON TIP CARDIAC PACING LEAD (P800041/S015) | Pacesetter Systems | 1996-01-04 |
| CARBON TIP CARDIAC PACING LEAD (P800041/S014) | Pacesetter Systems | 1994-10-17 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S011) | Pacesetter Systems | 1994-05-25 |
| CARBON TIPPED LEAD ALT.PROD.TRAYS (P800041/S012) | Pacesetter Systems | 1992-11-18 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S010) | Pacesetter Systems | 1990-12-18 |
| CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S009) | Pacesetter Systems | 1990-12-10 |
| ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008) | Pacesetter Systems | 1989-06-19 |
| ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S007) | Pacesetter Systems | 1987-06-22 |