FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MR-5200 FULL DISCLOSURE SYSTEM
K Number: K911257
·
Decision Aug 19, 1991
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
34
Review Days
151
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Basic Information
- Device Name
- MR-5200 FULL DISCLOSURE SYSTEM
- K Number
- K911257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mennen Medical, Inc.
- Date Received
- March 21, 1991
- Decision Date
- August 19, 1991
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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| K974510 | ENVOY PATIENT MONITOR | Apr 14, 1998 | Substantially Equivalent |
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| 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 |