The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Cuesee Hypoxic.
| Device ID | K152553 |
| 510k Number | K152553 |
| Device Name: | CueSee Hypoxic |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | EUROTROL B.V. KEPLERLAAN 20 Ede, NL 6716 Bs |
| Contact | Paul Kooijmans |
| Correspondent | Margherita La Marca EUROTROL B.V. KEPLERLAAN 20 Ede, NL 6716 Bs |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-08 |
| Decision Date | 2016-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718734960669 | K152553 | 000 |