CPAP System, Model 102001
FDA 510(k) K001318 · Sims Portex, Inc.
510(k) numberK001318
Submission
- Device name
- CPAP System, Model 102001
- Applicant
- Sims Portex, Inc.
Keene, NH, US - Received
- April 26, 2000
- Decision date
- July 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K103833 | Neopip Patient Circuit with PeepBYE · Traditional | Neoforce Group, Inc. | 04/20/2011SE |
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Questions and answers
When was CPAP System, Model 102001 cleared by the FDA?
CPAP System, Model 102001 (K001318) received a 510(k) decision of Substantially Equivalent on July 20, 2000, 85 days after the submission was received.
What is the product code of K001318?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.