The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Opus Pacemakers (models 4021, 4033, And 4034).
| Device ID | K952363 |
| 510k Number | K952363 |
| Device Name: | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) |
| Classification | Instrument, Hand, Calculus Removal |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Cahterine Goble |
| Correspondent | Cahterine Goble ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | ELA |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-08-15 |