FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
K Number: K013205
·
Decision Jul 2, 2002
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
18
Review Days
280
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
- K Number
- K013205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2060
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Millar Instruments, Inc.
- Date Received
- September 25, 2001
- Decision Date
- July 2, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRQ), ordered by most recent decision date.
ACIST RXi Mini System
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
FDA 510(k)
FDA Class 2
·Cardiovascular
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
FDA 510(k)
FDA Class 2
·Cardiovascular
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Millar Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112323 | CARDIA-CATH | Oct 18, 2011 | Substantially Equivalent |
| K093111 | MIKRO-CATH, MODEL 825-0101 | Jan 5, 2010 | Substantially Equivalent |
| K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER | Mar 1, 2000 | Substantially Equivalent |
| K952773 | MIKRO-TIP ANGIOGRAPHIC CATHETER | Nov 7, 1995 | Substantially Equivalent |
| K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER | Aug 5, 1994 | Substantially Equivalent |
| K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN | Apr 20, 1992 | Substantially Equivalent |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | Jan 24, 1990 | Substantially Equivalent |
| K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | Dec 7, 1989 | Substantially Equivalent |
| K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER | Nov 18, 1988 | Substantially Equivalent |
| K860766 | MILLAR PULSED DOPPLER VELOCIMETER | Jul 29, 1986 | Substantially Equivalent |