The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Digital Rectal Thermometer Sheath.
| Device ID | K183431 |
| 510k Number | K183431 |
| Device Name: | Medline Digital Rectal Thermometer Sheath |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Dinah Rincones |
| Correspondent | Dinah Rincones Medline Industries, Inc. Three Lakes 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 | 2018-12-11 |
| Decision Date | 2019-06-14 |