FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K Number: K874917
·
Decision May 10, 1988
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
48
Review Days
159
Basic Information
- Device Name
- PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
- K Number
- K874917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- OXFORD MEDILOG, INC.
- Date Received
- December 3, 1987
- Decision Date
- May 10, 1988
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
G0 Blood Pressure Monitoring System (G0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Globalcare Blood Pressure Monitor (GUS610)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by OXFORD MEDILOG, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K923737 | MODEL MEDILOG RAPIDE | Jan 5, 1994 | Substantially Equivalent |
| K920295 | MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) | Aug 18, 1992 | Substantially Equivalent |
| K912890 | MODEL SONICAID AXIS | Jan 9, 1992 | Substantially Equivalent |
| K912639 | SONICAID TEAM | Dec 31, 1991 | Substantially Equivalent |
| K904763 | MENTOR EEG SYSTEM | Apr 10, 1991 | Substantially Equivalent |
| K902690 | SONICAID MODEL MERIDIAN 800 | Feb 5, 1991 | Substantially Equivalent |
| K895909 | SONICAID MODEL VASOFLO 4 | Jul 9, 1990 | Substantially Equivalent |
| K896535 | MEDILOG OPTIMA | Jan 18, 1990 | Substantially Equivalent |
| K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM | Jun 1, 1989 | Substantially Equivalent |
| K890330 | MEDILOG 6000-FD REPORT GENERATOR | Apr 20, 1989 | Substantially Equivalent |