Breas PV 100 CPAP System
FDA 510(k) K001553 · Vital Signs, Inc.
510(k) numberK001553
Submission
- Device name
- Breas PV 100 CPAP System
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- May 18, 2000
- Decision date
- August 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
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| K112902 | Enflow IV Fluid WarmerLGZ · Traditional | 03/14/2012SE |
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| K022402 | Disposable Pressure ManometerCAP · Traditional | 08/22/2002SE |
| K021315 | Sure-LokFMI · Abbreviated | 08/21/2002SE |
| K002454 | Breas HA50 Humidifier, Model HA50BTT · Abbreviated | 03/07/2001SE |
| K000441 | BodyguardFMI · Traditional | 04/11/2000SE |
| K994044 | Cleen-AbleDXQ · Traditional | 02/25/2000SE |
| K990412 | Cuff-Able PlusDXQ · Traditional | 09/01/1999SE |
| K984468 | Vital PepBWF · Traditional | 06/01/1999SE |
Questions and answers
When was Breas PV 100 CPAP System cleared by the FDA?
Breas PV 100 CPAP System (K001553) received a 510(k) decision of Substantially Equivalent on August 3, 2000, 77 days after the submission was received.
What is the product code of K001553?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.