The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon 30 Second Reliable Digital Thermometer, Acon Digital Thermometer Probe Covers.
Device ID | K060173 |
510k Number | K060173 |
Device Name: | ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS |
Classification | Thermometer, Electronic, Clinical |
Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
Contact | Edward Tung |
Correspondent | Edward Tung 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 | 2006-01-23 |
Decision Date | 2006-03-17 |
Summary: | summary |