BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO— 510(k) K050006
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K050006 for BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO, Substantially Equivalent on 2005-05-27. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code DRQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2060
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lowell, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.