FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
K Number: K050006
·
Decision May 27, 2005
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
645
Review Days
144
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Basic Information
- Device Name
- BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
- K Number
- K050006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2060
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- January 3, 2005
- Decision Date
- May 27, 2005
- Product Code
- DRQ
- 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 |
|---|---|---|---|
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | FDA class 2 | Cardiovascular |
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