The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Digital Thermometer Probe Covers.
| Device ID | K063418 |
| 510k Number | K063418 |
| Device Name: | ACON DIGITAL THERMOMETER PROBE COVERS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Jinn-nan Lin, Ph.d |
| Correspondent | Jinn-nan Lin, Ph.d ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-02-02 |
| Summary: | summary |