The following data is part of a premarket notification filed by Epitest Ltd. Oy with the FDA for Finn Chamber (r).
| Device ID | K013820 |
| 510k Number | K013820 |
| Device Name: | FINN CHAMBER (R) |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | EPITEST LTD. OY 1330A REDWOOD WAY Petaluma, CA 94954 -1169 |
| Contact | Clawson Bowman |
| Correspondent | Clawson Bowman EPITEST LTD. OY 1330A REDWOOD WAY Petaluma, CA 94954 -1169 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-16 |
| Decision Date | 2002-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854498007488 | K013820 | 000 |
| 10854498007266 | K013820 | 000 |
| 10854498007365 | K013820 | 000 |
| 10854498007372 | K013820 | 000 |
| 10854498007389 | K013820 | 000 |
| 00854498007399 | K013820 | 000 |
| 10854498007402 | K013820 | 000 |
| 10854498007143 | K013820 | 000 |
| 10854498007150 | K013820 | 000 |
| 10854498007167 | K013820 | 000 |
| 10854498007174 | K013820 | 000 |
| 10854498007198 | K013820 | 000 |
| 10854498007228 | K013820 | 000 |
| 10854498007334 | K013820 | 000 |
| 10854498007341 | K013820 | 000 |
| 10854498007358 | K013820 | 000 |
| 10854498007242 | K013820 | 000 |