FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR
K Number: K864827
·
Decision Jan 21, 1987
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
30
Applicant Total
2
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR
- K Number
- K864827
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tactilitics, Inc.
- Date Received
- December 9, 1986
- Decision Date
- January 21, 1987
- Product Code
- KMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KMI | Monitor, Bed Patient | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMI), ordered by most recent decision date.
LEAF PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
INTEL-GE CARE INNOVATIONS QUIETCARE
FDA 510(k)
FDA Class 1
·General Hospital
DYNASENSE SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
VIVATRAK
FDA 510(k)
FDA Class 1
·General Hospital
MOBILECARE MONITOR, MODEL 2100
FDA 510(k)
FDA Class 1
·General Hospital
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Tactilitics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905586 | RSVP RF-2000 | Apr 1, 1991 | Substantially Equivalent |