The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Monitor, Model Hsm-00200; Probe, Model Hsp-05065; Jacket, Model Hsj-05065.
| Device ID | K031153 |
| 510k Number | K031153 |
| Device Name: | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | William G Mclain |
| Correspondent | William G Mclain ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-11 |
| Decision Date | 2003-11-25 |
| Summary: | summary |