The following data is part of a premarket notification filed by Elite Biomedical Solutions with the FDA for Elite Biomedical Solutions Dose Request Cord.
| Device ID | K220695 |
| 510k Number | K220695 |
| Device Name: | Elite Biomedical Solutions Dose Request Cord |
| Classification | Accessories, Pump, Infusion |
| Applicant | Elite Biomedical Solutions 756 Cincinnati-Batavia Pike Suite C Cincinnati, OH 45245 |
| Contact | Brenda Compliment |
| Correspondent | Brenda Compliment Elite Biomedical Solutions 756 Cincinnati-Batavia Pike Suite C Cincinnati, OH 45245 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-09 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008635402 | K220695 | 000 |