The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Modles 78354a/78352 Pulse Oximeter.
Device ID | K883297 |
510k Number | K883297 |
Device Name: | HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER |
Classification | Oximeter |
Applicant | HEWLETT-PACKARD CO. 175 WYMAN ST. Waltham, MA 02451 -1223 |
Contact | Nicholas Poly |
Correspondent | Nicholas Poly HEWLETT-PACKARD CO. 175 WYMAN ST. Waltham, MA 02451 -1223 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-04 |
Decision Date | 1988-10-06 |