The following data is part of a premarket notification filed by Vitalograph (ireland) Ltd. with the FDA for Vitalograph Model 6300 Micro.
| Device ID | K160253 |
| 510k Number | K160253 |
| Device Name: | Vitalograph Model 6300 Micro |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH (IRELAND) LTD. GORT ROAD BUSINESS PARK Ennis, IE V95 Hft4 |
| Contact | Tom J Healy |
| Correspondent | Tom J Healy VITALOGRAPH (IRELAND) LTD. GORT ROAD BUSINESS PARK Ennis, IE V95 Hft4 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169635203 | K160253 | 000 |
| 05099169633308 | K160253 | 000 |
| 05099169633100 | K160253 | 000 |
| 05099169633032 | K160253 | 000 |
| 05099169633018 | K160253 | 000 |
| 05099169633315 | K160253 | 000 |