The following data is part of a premarket notification filed by Nasogastric Feeding Solutions, Ltd. with the FDA for Doublechek Dc-1001.
| Device ID | K212316 |
| 510k Number | K212316 |
| Device Name: | DoubleChek DC-1001 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Nasogastric Feeding Solutions, Ltd. 131 Mount Pleasant Liverpool, GB L3 5TF |
| Contact | Mark Townend |
| Correspondent | Crystal Koelper Koelper Consulting, LLC 268 Biltmore Drive North Barrington, IL 60010 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-26 |
| Decision Date | 2022-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060692190040 | K212316 | 000 |