The following data is part of a premarket notification filed by Burke, Inc. with the FDA for Scout Boss.
| Device ID | K023961 |
| 510k Number | K023961 |
| Device Name: | SCOUT BOSS |
| Classification | Wheelchair, Powered |
| Applicant | BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106 |
| Contact | Duwayne E Kramer Jr. |
| Correspondent | Duwayne E Kramer Jr. BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-29 |
| Decision Date | 2002-12-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B314826771 | K023961 | 000 |
| B314826761 | K023961 | 000 |
| B314826281 | K023961 | 000 |
| B314823891 | K023961 | 000 |
| B314823481 | K023961 | 000 |
| B314820621 | K023961 | 000 |
| B313822501 | K023961 | 000 |