The following data is part of a premarket notification filed by Leica Microsystems, Inc. O.i.d. with the FDA for Portable Non-contact Tonometer, Model Pt100.
| Device ID | K013259 |
| 510k Number | K013259 |
| Device Name: | PORTABLE NON-CONTACT TONOMETER, MODEL PT100 |
| Classification | Tonometer, Ac-powered |
| Applicant | LEICA MICROSYSTEMS, INC. O.I.D. 3374 WALDEN AVE. Depew, NY 14043 |
| Contact | Frank J Drexelius |
| Correspondent | Frank J Drexelius LEICA MICROSYSTEMS, INC. O.I.D. 3374 WALDEN AVE. Depew, NY 14043 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2002-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559010429 | K013259 | 000 |