The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Model M1018a Tcpo2/topco2 Module.
| Device ID | K925910 |
| 510k Number | K925910 |
| Device Name: | HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Contact | Van Dyk |
| Correspondent | Van Dyk HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-23 |
| Decision Date | 1993-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074668 | K925910 | 000 |
| 00884838074651 | K925910 | 000 |
| 00884838073609 | K925910 | 000 |
| 00884838021006 | K925910 | 000 |
| 00884838010000 | K925910 | 000 |