The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Co. Rechargeable Battery Part Number Ms311.
Device ID | K972086 |
510k Number | K972086 |
Device Name: | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 |
Classification | Spirometer, Monitoring (w/wo Alarm) |
Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Contact | Ken Heimendinger |
Correspondent | Ken Heimendinger ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Product Code | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-04 |
Decision Date | 1997-08-12 |