The following data is part of a premarket notification filed by Apollo Enterprise, Ltd. Co. with the FDA for Sentry Scale.
Device ID | K905122 |
510k Number | K905122 |
Device Name: | SENTRY SCALE |
Classification | Scale, Patient |
Applicant | APOLLO ENTERPRISE, LTD. CO. P.O. BOX 218 Somerset, WI 54025 |
Contact | Adrian Sween |
Correspondent | Adrian Sween APOLLO ENTERPRISE, LTD. CO. P.O. BOX 218 Somerset, WI 54025 |
Product Code | FRW |
CFR Regulation Number | 880.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-14 |
Decision Date | 1991-03-15 |