The following data is part of a premarket notification filed by Keller Medical Specialties Products, Inc. with the FDA for Keller Vital Signs Monitor - Kms-890.
Device ID | K910262 |
510k Number | K910262 |
Device Name: | KELLER VITAL SIGNS MONITOR - KMS-890 |
Classification | Alarm, Blood-pressure |
Applicant | KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
Contact | Jay Keller |
Correspondent | Jay Keller KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
Product Code | DSJ |
CFR Regulation Number | 870.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-22 |
Decision Date | 1991-04-01 |