CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
FDA 510(k) K150235 · Boston Scientific Corporation
510(k) numberK150235
Submission
- Device name
- CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
- Applicant
- Boston Scientific Corporation
Lowell, MA, US - Received
- February 2, 2015
- Decision date
- April 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRQ – Amplifier And Signal Conditioner, Transducer Signal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2060
- Specialty
- Cardiovascular
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Questions and answers
When was CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels cleared by the FDA?
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (K150235) received a 510(k) decision of Substantially Equivalent on April 22, 2015, 79 days after the submission was received.
What is the product code of K150235?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.