The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for R-band(tm) Respiratory Sensor.
Device ID | K900264 |
510k Number | K900264 |
Device Name: | R-BAND(TM) RESPIRATORY SENSOR |
Classification | Monitor, Breathing Frequency |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-18 |
Decision Date | 1990-07-24 |