The following data is part of a premarket notification filed by Mcneill Intl., Inc. with the FDA for Vitalograph - Breathco Monitor.
| Device ID | K902113 |
| 510k Number | K902113 |
| Device Name: | VITALOGRAPH - BREATHCO MONITOR |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | MCNEILL INTL., INC. 2904 BISHOP RD. Willoughby, OH 44092 |
| Contact | Allan Mcneill |
| Correspondent | Allan Mcneill MCNEILL INTL., INC. 2904 BISHOP RD. Willoughby, OH 44092 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-11 |
| Decision Date | 1990-10-26 |