The following data is part of a premarket notification filed by Vitalograph Ireland Ltd. with the FDA for Model 9100 Pft/dico.
| Device ID | K221030 |
| 510k Number | K221030 |
| Device Name: | Model 9100 PFT/DICO |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare, IE V95 HFT4 |
| Contact | Tony O'Hanlon |
| Correspondent | Paul Dryden ProMedic, LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169915107 | K221030 | 000 |
| 05099169913103 | K221030 | 000 |
| 05099169919105 | K221030 | 000 |