Millar Pressure Control Unit Model PCU-2000
FDA 510(k) K013205 · Millar Instruments, Inc.
510(k) numberK013205
Submission
- Device name
- Millar Pressure Control Unit Model PCU-2000
- Applicant
- Millar Instruments, Inc.
Houston, TX, US - Received
- September 25, 2001
- Decision date
- July 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Millar Pressure Control Unit Model PCU-2000 cleared by the FDA?
Millar Pressure Control Unit Model PCU-2000 (K013205) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 280 days after the submission was received.
What is the product code of K013205?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.