The following data is part of a premarket notification filed by Apex Medical, Inc. with the FDA for Pulsar Em.
| Device ID | K882816 |
| 510k Number | K882816 |
| Device Name: | PULSAR EM |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
| Contact | Larry Inman |
| Correspondent | Larry Inman APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-08 |
| Decision Date | 1989-04-27 |