The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Mpc (model 7000) External Temporary Pacemaker System.
| Device ID | K970347 |
| 510k Number | K970347 |
| Device Name: | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-27 |
| Decision Date | 1997-08-29 |
| Summary: | summary |