The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Disposable Electronic Thermometer Probe Cover.
| Device ID | K173113 |
| 510k Number | K173113 |
| Device Name: | Medline Disposable Electronic Thermometer Probe Cover |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Medline Industries, Inc. Three Lake Drive Northfield, IL 60093 |
| Contact | Dinah Rincones |
| Correspondent | Dinah Rincones Medline Industries, Inc. Three Lake Drive Northfield, IL 60093 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888277116522 | K173113 | 000 |
| 00888277116514 | K173113 | 000 |
| 00888277115425 | K173113 | 000 |
| 10888277628373 | K173113 | 000 |
| 40193489383950 | K173113 | 000 |