The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph-breathco Monitor.
| Device ID | K892524 |
| 510k Number | K892524 |
| Device Name: | VITALOGRAPH-BREATHCO MONITOR |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Lovina Freeman |
| Correspondent | Lovina Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169297500 | K892524 | 000 |
| 15099196297501 | K892524 | 000 |