The following data is part of a premarket notification filed by Optilasa S.l. with the FDA for Applanation Tonometer.
| Device ID | K023676 |
| 510k Number | K023676 |
| Device Name: | APPLANATION TONOMETER |
| Classification | Tonometer, Ac-powered |
| Applicant | OPTILASA S.L. 338 ARTURO SORIA ST. Madrid, ES 28033 |
| Contact | Jose M Bobes |
| Correspondent | Jose M Bobes OPTILASA S.L. 338 ARTURO SORIA ST. Madrid, ES 28033 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2003-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869228000441 | K023676 | 000 |
| 00851158007119 | K023676 | 000 |
| 00851158007102 | K023676 | 000 |