The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Picf 0860/pscf 0860/psc 0860/piaf 0860/psaf 0860.
| Device ID | K872731 |
| 510k Number | K872731 |
| Device Name: | PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Tom S Anderson |
| Correspondent | Tom S Anderson ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-08 |
| Decision Date | 1987-09-15 |