FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HORIZON 2000 EEG MONITORING OPTION
K Number: K910945
·
Decision Aug 15, 1991
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
34
Review Days
162
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Basic Information
- Device Name
- HORIZON 2000 EEG MONITORING OPTION
- K Number
- K910945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Mennen Medical, Inc.
- Date Received
- March 6, 1991
- Decision Date
- August 15, 1991
- Product Code
- GWQ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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| K982697 | MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR | Aug 12, 1998 | Substantially Equivalent |
| K974510 | ENVOY PATIENT MONITOR | Apr 14, 1998 | Substantially Equivalent |
| K970358 | ENSEMBLE CENTRAL STATION MONITOR | Feb 11, 1998 | Substantially Equivalent |
| K940081 | MERCURY | Apr 12, 1995 | Substantially Equivalent |
| K940415 | HORIZON 9000 WS | Jan 6, 1995 | Substantially Equivalent |
| K920915 | CAPNOMED 100 STAND-ALONE ETCO2 MODULE | Mar 23, 1993 | Substantially Equivalent |
| K914381 | HORIZON 9000/HIS OPTION AMPLIFIER | Jan 28, 1992 | Substantially Equivalent |