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 |