The following data is part of a premarket notification filed by Itamar Medical with the FDA for Endo Pat 2000.
| Device ID | K032519 |
| 510k Number | K032519 |
| Device Name: | ENDO PAT 2000 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ITAMAR MEDICAL 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz ITAMAR MEDICAL 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-15 |
| Decision Date | 2003-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109225388 | K032519 | 000 |
| 07290109225364 | K032519 | 000 |
| 07290109225357 | K032519 | 000 |
| 07290109225340 | K032519 | 000 |
| 07290109225210 | K032519 | 000 |
| 07290109225203 | K032519 | 000 |
| 07290109225005 | K032519 | 000 |