FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BM3/BM3 PLUS
K Number: K132033
·
Decision Dec 4, 2013
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
301
Applicant Total
1
Review Days
156
Basic Information
- Device Name
- BM3/BM3 PLUS
- K Number
- K132033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NOBLITT & RUELAND
- Date Received
- July 1, 2013
- Decision Date
- December 4, 2013
- 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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