The following data is part of a premarket notification filed by National Custom Ent., Inc. with the FDA for Nce Replacement Batteries.
| Device ID | K942629 |
| 510k Number | K942629 |
| Device Name: | NCE REPLACEMENT BATTERIES |
| Classification | Electrocardiograph |
| Applicant | NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD. Burnsville, MN 55337 -2559 |
| Contact | Michael A Benyo |
| Correspondent | Michael A Benyo NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD. Burnsville, MN 55337 -2559 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1994-08-18 |