Modified Models 9500,9550,9200,8200,HEART Rate Mon
FDA 510(k) K902785 · Aequitron Medical, Inc.
510(k) numberK902785
Submission
- Device name
- Modified Models 9500,9550,9200,8200,HEART Rate Mon
- Applicant
- Aequitron Medical, Inc.
Plymouth, MN, US - Received
- June 26, 1990
- Decision date
- July 13, 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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More from Linshom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961972 | Model Ami Infant Central Aphea/Heart Rate MonitorBZQ · Traditional | 04/18/1997ST |
| K952880 | Model LP-1000 Volume VentilatorCBK · Traditional | 06/20/1996ST |
| K944654 | Oxygen Concentration IndicatorCCL · Traditional | 11/08/1994SE |
| K914424 | Model 6213 Remote AlarmCBK · Traditional | 09/10/1992SE |
| K915381 | Portable Oxygen GeneratorCAW · Traditional | 03/11/1992SE |
| 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 |
| K901656 | Model 9200 Respiration/Heart Rate MonitorBZQ · Traditional | 07/13/1990SE |
Questions and answers
When was Modified Models 9500,9550,9200,8200,HEART Rate Mon cleared by the FDA?
Modified Models 9500,9550,9200,8200,HEART Rate Mon (K902785) received a 510(k) decision of Substantially Equivalent on July 13, 1990, 17 days after the submission was received.
What is the product code of K902785?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.