The following data is part of a premarket notification filed by Vitalograph Ireland Ltd. with the FDA for Vitalograph Model 6000 Alpha.
| Device ID | K212938 |
| 510k Number | K212938 |
| Device Name: | Vitalograph Model 6000 Alpha |
| Classification | Spirometer, Diagnostic |
| Applicant | Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare, IE V95 Hft4 |
| Contact | Tony O'hanlon |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-15 |
| Decision Date | 2022-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169690028 | K212938 | 000 |