The following data is part of a premarket notification filed by Yamasu Co. Ltd. with the FDA for Aneroid Sphygmomanometer, Doctor Type.
Device ID | K901506 |
510k Number | K901506 |
Device Name: | ANEROID SPHYGMOMANOMETER, DOCTOR TYPE |
Classification | Blood Pressure Cuff |
Applicant | YAMASU CO. LTD. 100 NUKUI KAMIKAWA MURA KODAMA GUN Saitama Pref., JP |
Contact | Watanabe |
Correspondent | Watanabe YAMASU CO. LTD. 100 NUKUI KAMIKAWA MURA KODAMA GUN Saitama Pref., JP |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-30 |
Decision Date | 1990-05-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04560105682465 | K901506 | 000 |