The following data is part of a premarket notification filed by Macosta Medical Usa, Llc with the FDA for B-smart, Model B-01.
| Device ID | K031128 |
| 510k Number | K031128 |
| Device Name: | B-SMART, MODEL B-01 |
| Classification | Anesthesia Conduction Kit |
| Applicant | MACOSTA MEDICAL USA, LLC 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau MACOSTA MEDICAL USA, LLC 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-09 |
| Decision Date | 2004-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18053676290014 | K031128 | 000 |