The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Cardiac Catheterization Recording.
| Device ID | K921194 |
| 510k Number | K921194 |
| Device Name: | HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Contact | Peter Childs |
| Correspondent | Peter Childs HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-12 |
| Decision Date | 1992-11-09 |