Biochem 515 Respiration Monitor
FDA 510(k) K854333 · Biochem International, Inc.
510(k) numberK854333
Submission
- Device name
- Biochem 515 Respiration Monitor
- Applicant
- Biochem International, Inc.
Waukesha, WI, US - Received
- October 28, 1985
- Decision date
- May 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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| K903222 | Biochem 6100 Non-Invasive MonitorDXN · Traditional | 09/04/1990SE |
| K901861 | Biochem 9100 Multigas MonitorCCK · Traditional | 07/27/1990SE |
| K893877 | Biochem 3100 OximeterDQO · Traditional | 12/20/1989SE |
| K892646 | Biochem 8100 Anesthetic Agent MonitorCBQ · Traditional | 08/31/1989SE |
Questions and answers
When was Biochem 515 Respiration Monitor cleared by the FDA?
Biochem 515 Respiration Monitor (K854333) received a 510(k) decision of Substantially Equivalent on May 30, 1986, 214 days after the submission was received.
What is the product code of K854333?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.