FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K Number: K011177
·
Decision May 23, 2001
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
13
Review Days
36
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BCI ADVISOR VITAL SIGNS MONITOR (9200)
- K Number
- K011177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bci, Inc.
- Date Received
- April 17, 2001
- Decision Date
- May 23, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.
MAC 7 Resting ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
AccurECG Analysis System (v2.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Withings BeamO (SCT02)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiologs Holter Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
ZBPro Diagnostic
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K010770 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | Jun 12, 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 |