| Device Classification Name |
Monitor, Bed Patient
|
| 510(k) Number |
K864827 |
| Device Name |
RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR |
| Applicant |
| Tactilitics, Inc. |
| 1021 Pearl St. |
|
Boulder,
CO
80302
|
|
| Applicant Contact |
GEORGE BEGGS |
| Correspondent |
| Tactilitics, Inc. |
| 1021 Pearl St. |
|
Boulder,
CO
80302
|
|
| Correspondent Contact |
GEORGE BEGGS |
| Regulation Number | 880.2400 |
| Classification Product Code |
|
| Date Received | 12/09/1986 |
| Decision Date | 01/21/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|