The following data is part of a premarket notification filed by Vitalograph(ireland) Ltd. with the FDA for Vitalograph Hand Held Spirometer, Model 2120.
| Device ID | K100687 |
| 510k Number | K100687 |
| Device Name: | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD BUSINESS PARK Ennis, Co. Clare, IE |
| Contact | Tom J Healy |
| Correspondent | Tom J Healy VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD BUSINESS PARK Ennis, Co. Clare, IE |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169794016 | K100687 | 000 |
| 05099169793019 | K100687 | 000 |
| 05099169790018 | K100687 | 000 |
| 05099169796744 | K100687 | 000 |
| 05099169790490 | K100687 | 000 |