The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Hp Orvue Intra-op (m2510a).
| Device ID | K965160 |
| 510k Number | K965160 |
| Device Name: | HP ORVUE INTRA-OP (M2510A) |
| Classification | Gas-machine, Anesthesia |
| Applicant | HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Contact | Herbert Van Dyk |
| Correspondent | Herbert Van Dyk HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-09-11 |
| Summary: | summary |