The following data is part of a premarket notification filed by Cheung Laboratories, Inc. with the FDA for Diathermy Device-microfocus.
| Device ID | K941567 |
| 510k Number | K941567 |
| Device Name: | DIATHERMY DEVICE-MICROFOCUS |
| Classification | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | CHEUNG LABORATORIES, INC. 10220 - I OLD COLUMBIA RD. Columbia, MD 21046 -1890 |
| Contact | Dennis Smith |
| Correspondent | Dennis Smith CHEUNG LABORATORIES, INC. 10220 - I OLD COLUMBIA RD. Columbia, MD 21046 -1890 |
| Product Code | IOA |
| CFR Regulation Number | 890.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1996-04-22 |