The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 515 Respiration Monitor.
| Device ID | K854333 |
| 510k Number | K854333 |
| Device Name: | BIOCHEM 515 RESPIRATION MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | Keith R Harper |
| Correspondent | Keith R Harper BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1986-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426638170700 | K854333 | 000 |