FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
K Number: K922668
·
Decision Jan 29, 1997
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
15
Review Days
1700
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Basic Information
- Device Name
- PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
- K Number
- K922668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Colin Medical Instruments Corp.
- Date Received
- June 4, 1992
- Decision Date
- January 29, 1997
- Product Code
- MHX
- 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 |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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| K921048 | BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST | Jul 1, 1993 | Substantially Equivalent |
| K900247 | CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM | Jul 17, 1990 | Substantially Equivalent |
| K890876 | BP-8800 BLOOD PRESSURE MONITOR | Jun 22, 1989 | Substantially Equivalent |
| K884822 | MODEL OX-1 OXYGEN SATURATION MODULE | Mar 2, 1989 | Substantially Equivalent |
| K884896 | BP-308 MARK II | Feb 23, 1989 | Substantially Equivalent |
| K884885 | BP-408 MARK II | Feb 23, 1989 | Substantially Equivalent |