FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HORIZON 1000 CARDIAC MONITOR
K Number: K850880
·
Decision Apr 25, 1985
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
34
Review Days
52
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Basic Information
- Device Name
- HORIZON 1000 CARDIAC MONITOR
- K Number
- K850880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mennen Medical, Inc.
- Date Received
- March 4, 1985
- Decision Date
- April 25, 1985
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Mennen Medical, Inc.
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|---|---|---|---|
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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 |