The following data is part of a premarket notification filed by Direct Solutions with the FDA for Eurotrol Gas - Ise Control.
| Device ID | K955340 |
| 510k Number | K955340 |
| Device Name: | EUROTROL GAS - ISE CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 Westford, MA 01886 |
| Contact | William R Donohue |
| Correspondent | William R Donohue DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 Westford, MA 01886 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1995-12-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718734961109 | K955340 | 000 |