The following data is part of a premarket notification filed by Vitalograph(ireland) Ltd. with the FDA for Vitalograph Model 7000 Spirotrac.
| Device ID | K141546 |
| 510k Number | K141546 |
| Device Name: | VITALOGRAPH MODEL 7000 SPIROTRAC |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD BUSINESS PARK Ennis, Co. Clare, IE |
| Contact | Tom J Healy |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-06-10 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169777330 | K141546 | 000 |
| 05099169777019 | K141546 | 000 |
| 05099169770010 | K141546 | 000 |
| 05099169706101 | K141546 | 000 |
| 15099169676739 | K141546 | 000 |
| 05099169706088 | K141546 | 000 |
| 15099169676760 | K141546 | 000 |
| 05099169688001 | K141546 | 000 |