FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KELLER VITAL SIGNS MONITOR - KMS-890
K Number: K910262
·
Decision Apr 1, 1991
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
5
Applicant Total
6
Review Days
69
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
- KELLER VITAL SIGNS MONITOR - KMS-890
- K Number
- K910262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Keller Medical Specialties Products, Inc.
- Date Received
- January 22, 1991
- Decision Date
- April 1, 1991
- Product Code
- DSJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSJ | Alarm, Blood-Pressure | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSJ), ordered by most recent decision date.
EarlyVue VS30
FDA 510(k)
FDA Class 2
·Cardiovascular
SureSigns VS3; SureSigns VS4
FDA 510(k)
FDA Class 2
·Cardiovascular
SureSigns VS3, SureSigns VS4
FDA 510(k)
FDA Class 2
·Cardiovascular
SURESIGNS VS3, SURESIGNS VS4
FDA 510(k)
FDA Class 2
·Cardiovascular
SAMS 8000 CARDIOPLEGIA MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Keller Medical Specialties Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990648 | KELLER VITAL SIGNS MONITOR, KMS 890+ | Aug 10, 1999 | Substantially Equivalent |
| K982331 | KELLER PULSE OXIMETER, MODEL 850+ | Sep 11, 1998 | Substantially Equivalent |
| K914576 | KELLER CARDIAC MONITOR MEDIL KMS870 | Dec 30, 1991 | Substantially Equivalent |
| K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | Nov 16, 1990 | Substantially Equivalent |
| K895987 | KELLER PULSE OXIMETER - KMS 850 | Feb 22, 1990 | Substantially Equivalent |