The following data is part of a premarket notification filed by Pan Dynamics Medical Corp. with the FDA for Disposable Tissue Effect Biosensor-t.
| Device ID | K843157 |
| 510k Number | K843157 |
| Device Name: | DISPOSABLE TISSUE EFFECT BIOSENSOR-T |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | PAN DYNAMICS MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-10 |
| Decision Date | 1984-09-19 |