Breathguard Apnea Monitor
FDA 510(k) K872833 · Lada Intl., Inc.
510(k) numberK872833
Submission
- Device name
- Breathguard Apnea Monitor
- Applicant
- Lada Intl., Inc.
Arlington Heights, IL, US - Received
- July 17, 1987
- Decision date
- April 1, 1988
- 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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Questions and answers
When was Breathguard Apnea Monitor cleared by the FDA?
Breathguard Apnea Monitor (K872833) received a 510(k) decision of Substantially Equivalent on April 1, 1988, 259 days after the submission was received.
What is the product code of K872833?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.