The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Neonatal/sterile/dispos/noninvas Blood Press Cuff.
Device ID | K905101 |
510k Number | K905101 |
Device Name: | NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF |
Classification | Blood Pressure Cuff |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | Donald A Guthrie |
Correspondent | Donald A Guthrie HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-13 |
Decision Date | 1990-12-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838008250 | K905101 | 000 |
20884838008506 | K905101 | 000 |
20884838008513 | K905101 | 000 |
20884838008520 | K905101 | 000 |
20884838008537 | K905101 | 000 |
20884838008544 | K905101 | 000 |
20884838008551 | K905101 | 000 |
20884838008568 | K905101 | 000 |
20884838008575 | K905101 | 000 |
20884838008582 | K905101 | 000 |
00884838008243 | K905101 | 000 |
20884838008490 | K905101 | 000 |