Healthdyne's Apnea/Heart Monitor, Model 900S
FDA 510(k) K892006 · Healthdyne, Inc.
510(k) numberK892006
Submission
- Device name
- Healthdyne's Apnea/Heart Monitor, Model 900S
- Applicant
- Healthdyne, Inc.
Marietta, GA, US - Received
- March 28, 1989
- Decision date
- May 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
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| K922623 | Nebulizer SystemBTI · Traditional | 12/01/1992SE |
| K910118 | Data RecorderFLL · Traditional | 02/14/1991SE |
| K903287 | Model 900S Apnea/Heart MonitorBZQ · Traditional | 08/17/1990SE |
| K894030 | Model 37 Uterine Contraction Activity MonitorHFM · Traditional | 01/22/1990SE |
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Questions and answers
When was Healthdyne's Apnea/Heart Monitor, Model 900S cleared by the FDA?
Healthdyne's Apnea/Heart Monitor, Model 900S (K892006) received a 510(k) decision of Substantially Equivalent on May 23, 1989, 56 days after the submission was received.
What is the product code of K892006?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.