The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Pressure Control Unit Model Pcu-2000.
| Device ID | K013205 |
| 510k Number | K013205 |
| Device Name: | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Contact | Monica R Montanez |
| Correspondent | Monica R Montanez MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2002-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868924000212 | K013205 | 000 |