The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Breath Control (breath Actuator), Sensitouch Breath Control, Head Array (switch Head Control), Tri-switch Head Array, Hd.
| Device ID | K983520 |
| 510k Number | K983520 |
| Device Name: | BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD |
| Classification | Wheelchair, Powered |
| Applicant | SUNRISE MEDICAL, INC. 7477A EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen SUNRISE MEDICAL, INC. 7477A EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1998-11-06 |
| Summary: | summary |