The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for External Helium Supply (accessory For Iabp).
| Device ID | K950687 |
| 510k Number | K950687 |
| Device Name: | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) |
| 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 | 1995-02-14 |
| Decision Date | 1995-05-24 |