Model Ami Infant Central Aphea/Heart Rate Monitor
FDA 510(k) K961972 · Aequitron Medical, Inc.
510(k) numberK961972
Submission
- Device name
- Model Ami Infant Central Aphea/Heart Rate Monitor
- Applicant
- Aequitron Medical, Inc.
Plymouth, MN, US - Received
- May 20, 1996
- Decision date
- April 18, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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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| K952880 | Model LP-1000 Volume VentilatorCBK · Traditional | 06/20/1996ST |
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| K911399 | Nasal CPAP (Continuous Positive Air Pressure Syst)DZD · Traditional | 09/19/1991SE |
| K903020 | Respiration/Heart Rate Monitor Model 9500/9550BZQ · Traditional | 04/10/1991SE |
| K905244 | Model LP6 Ventilator, ModificationCBK · Traditional | 11/30/1990SE |
| K903010 | Continuous Volume Ventilator Model LP10CBK · Traditional | 11/30/1990SE |
| K902785 | Modified Models 9500,9550,9200,8200,HEART Rate MonBZQ · Traditional | 07/13/1990SE |
| K901656 | Model 9200 Respiration/Heart Rate MonitorBZQ · Traditional | 07/13/1990SE |
Questions and answers
When was Model Ami Infant Central Aphea/Heart Rate Monitor cleared by the FDA?
Model Ami Infant Central Aphea/Heart Rate Monitor (K961972) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on April 18, 1997, 333 days after the submission was received.
What is the product code of K961972?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.