FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
6200 VITAL SIGNS MONITOR
K Number: K953415
·
Decision Oct 19, 1995
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
20
Review Days
91
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Basic Information
- Device Name
- 6200 VITAL SIGNS MONITOR
- K Number
- K953415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bci Intl., Inc.
- Date Received
- July 20, 1995
- Decision Date
- October 19, 1995
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Bci Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991086 | CAPNOCHECK II, MODEL 8400 | Jun 9, 1999 | Substantially Equivalent |
| K991410 | 3402 HANDHELD PULSE OXIMETER | Jun 9, 1999 | Substantially Equivalent |
| K984618 | BCI MINI-TORR PLUS, MODEL 6004 | Mar 25, 1999 | Substantially Equivalent |
| K983796 | 6004 NIBP MONITOR WITH TEMPERATURE | Jan 22, 1999 | Substantially Equivalent |
| K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | Sep 25, 1998 | Substantially Equivalent |
| K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR | Aug 20, 1998 | Substantially Equivalent |
| K980714 | BCI 3401 HANDHELD PULSE OXIMETER | Mar 25, 1998 | Substantially Equivalent |
| K974697 | REUSABLE FINGER SENSOR 3444 | Mar 11, 1998 | Substantially Equivalent |
| K970801 | BCI MODEL 6004 NIBP MONITOR (6004) | Nov 12, 1997 | Substantially Equivalent |
| K970209 | CAPNOCHECK PLUS | Apr 18, 1997 | Substantially Equivalent |