The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Hand Aneroid Sphygmomanometer.
Device ID | K940493 |
510k Number | K940493 |
Device Name: | HAND ANEROID SPHYGMOMANOMETER |
Classification | Blood Pressure Cuff |
Applicant | WELCH ALLYN, INC. 950LD SHOALS RD. Arden, NC 28704 |
Contact | Larry Williams |
Correspondent | Larry Williams WELCH ALLYN, INC. 950LD SHOALS RD. Arden, NC 28704 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-02 |
Decision Date | 1994-07-01 |