Edentec Model 2000W Apnea Monitor
FDA 510(k) K844327 · Edentec Corp.
510(k) numberK844327
Submission
- Device name
- Edentec Model 2000W Apnea Monitor
- Applicant
- Edentec Corp.
Eden Prairie, MN, US - Received
- November 7, 1984
- Decision date
- July 15, 1985
- 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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| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | 08/29/1991SE |
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| K905575 | Modified Models 2000W and 2000W Option H Apnea MonBZQ · Traditional | 06/20/1991SE |
| K901060 | Edentec Model 2000W System 700 MonitorDQA · Traditional | 05/15/1990SE |
| K893561 | Edentrace 670 System Multichannel Recorder W/Oxim.DSF · Traditional | 08/25/1989SE |
| K892227 | Edentec Model 2001 Modular Memory Unit (Mmu)DSH · Traditional | 06/20/1989SE |
Questions and answers
When was Edentec Model 2000W Apnea Monitor cleared by the FDA?
Edentec Model 2000W Apnea Monitor (K844327) received a 510(k) decision of Substantially Equivalent on July 15, 1985, 250 days after the submission was received.
What is the product code of K844327?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.