The following data is part of a premarket notification filed by Vitalograph(ireland) Ltd. with the FDA for Vitalograph Model 7100 - Vitalojak.
| Device ID | K110525 |
| 510k Number | K110525 |
| Device Name: | VITALOGRAPH MODEL 7100 - VITALOJAK |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD BUSINESS PARK Ennis, Co. Clare, IE Ei |
| Contact | Tom J Healy |
| Correspondent | Tom J Healy VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD BUSINESS PARK Ennis, Co. Clare, IE Ei |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-23 |
| Decision Date | 2011-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169715103 | K110525 | 000 |
| 05099169710238 | K110525 | 000 |
| 05099169710023 | K110525 | 000 |
| 05099169715110 | K110525 | 000 |