FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K Number: K860124
·
Decision May 9, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
34
Review Days
115
Basic Information
- Device Name
- HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
- K Number
- K860124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- MENNEN MEDICAL, INC.
- Date Received
- January 14, 1986
- Decision Date
- May 9, 1986
- Product Code
- KLK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
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Other Clearances by MENNEN MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K030722 | ENVOY PATIENT MONITOR | Feb 26, 2004 | Substantially Equivalent |
| K983864 | ETCO2 VITAL SIGNS MODULE | Oct 8, 1999 | Substantially Equivalent |
| K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS | Jun 24, 1999 | Substantially Equivalent |
| 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 |