The following data is part of a premarket notification filed by Vitalograph(ireland) Ltd. with the FDA for Vitalograph Model 6800 Pneumotrac.
| Device ID | K142812 |
| 510k Number | K142812 |
| Device Name: | Vitalograph Model 6800 Pneumotrac |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH(IRELAND) LTD. Gort Road Business Park Ennis, IE |
| Contact | Tom J Healy |
| Correspondent | Tom J Healy VITALOGRAPH(IRELAND) LTD. Gort Road Business Park Ennis, IE |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169777521 | K142812 | 000 |
| 05099169777323 | K142812 | 000 |
| 05099169770522 | K142812 | 000 |
| 05099169770508 | K142812 | 000 |
| 05099169777576 | K142812 | 000 |
| 05099169779020 | K142812 | 000 |
| 05099169779723 | K142812 | 000 |
| 05099169779778 | K142812 | 000 |
| 05099169779570 | K142812 | 000 |