The following data is part of a premarket notification filed by Good Medy Enterprise Ltd. with the FDA for Good Medy, Disposable Thermometer Sheaths.
| Device ID | K061007 |
| 510k Number | K061007 |
| Device Name: | GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GOOD MEDY ENTERPRISE LTD. 1 F., NO. 72, ALLEY 33 LANE 514, JONGIENG ROAD Shingjuang City, Taipei, TW 24255 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min GOOD MEDY ENTERPRISE LTD. 1 F., NO. 72, ALLEY 33 LANE 514, JONGIENG ROAD Shingjuang City, Taipei, TW 24255 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-11 |
| Decision Date | 2006-06-14 |
| Summary: | summary |