Model 900S Apnea/Heart Monitor
FDA 510(k) K903287 · Healthdyne, Inc.
510(k) numberK903287
Submission
- Device name
- Model 900S Apnea/Heart Monitor
- Applicant
- Healthdyne, Inc.
Marietta, GA, US - Received
- July 11, 1990
- Decision date
- August 17, 1990
- 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 Model 900S Apnea/Heart Monitor cleared by the FDA?
Model 900S Apnea/Heart Monitor (K903287) received a 510(k) decision of Substantially Equivalent on August 17, 1990, 37 days after the submission was received.
What is the product code of K903287?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.