The following data is part of a premarket notification filed by Aframe Digital, Inc. with the FDA for Mobilecare Monitor, Model 2100.
| Device ID | K090138 |
| 510k Number | K090138 |
| Device Name: | MOBILECARE MONITOR, MODEL 2100 |
| Classification | Monitor, Bed Patient |
| Applicant | AFRAME DIGITAL, INC. 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves AFRAME DIGITAL, INC. 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-24 |
| Summary: | summary |