FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K Number: K010770
·
Decision Jun 12, 2001
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- BCI ADVISOR VITAL SIGNS MONITOR (9200)
- K Number
- K010770
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bci, Inc.
- Date Received
- March 14, 2001
- Decision Date
- June 12, 2001
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Bci, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030407 | ADVISOR, MODEL 9200 | Aug 19, 2003 | Substantially Equivalent |
| K031742 | BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER | Aug 18, 2003 | Substantially Equivalent |
| K020739 | BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR | Jun 3, 2002 | Substantially Equivalent |
| K020350 | BCI 3180 PULSE OXIMETER | Apr 30, 2002 | Substantially Equivalent |
| K013862 | BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM | Feb 21, 2002 | Substantially Equivalent |
| K013171 | 3420 DIGIT PULSE OXIMETER, MODEL 3420 | Jan 3, 2002 | Substantially Equivalent |
| K011156 | BCI 3403 SLEEP SCREENING PULSE OXIMETER | Jun 14, 2001 | Substantially Equivalent |
| K011177 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | May 23, 2001 | Substantially Equivalent |
| K001770 | BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A | Jul 5, 2000 | Substantially Equivalent |
| K944121 | SHARPS CONTAINER 18 GALLON | Jan 27, 1995 | Substantially Equivalent |