The following data is part of a premarket notification filed by Care Electronics, Inc. with the FDA for Wander Care.
| Device ID | K925529 |
| 510k Number | K925529 |
| Device Name: | WANDER CARE |
| Classification | Monitor, Bed Patient |
| Applicant | CARE ELECTRONICS, INC. 5741 ARAPAHOE RD. SUITE 2A Boulder, CO 80303 |
| Contact | Thomas O Moody |
| Correspondent | Thomas O Moody CARE ELECTRONICS, INC. 5741 ARAPAHOE RD. SUITE 2A Boulder, CO 80303 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-06-16 |