The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Model 30 Classic Pneumatonometer.
| Device ID | K002395 |
| 510k Number | K002395 |
| Device Name: | MODEL 30 CLASSIC PNEUMATONOMETER |
| Classification | Tonometer, Ac-powered |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Diana Preston |
| Correspondent | Diana Preston XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559010979 | K002395 | 000 |
| 00812559010962 | K002395 | 000 |
| 00812559010955 | K002395 | 000 |