The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Belmont Model Ngpbp Intra-aortic Balloon Pump.
| Device ID | K983866 |
| 510k Number | K983866 |
| Device Name: | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Contact | Uraiwan P Labadini |
| Correspondent | Uraiwan P Labadini BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 2000-01-06 |
| Summary: | summary |