Devilbiss Model 7351D Revitalizer CPAP System
FDA 510(k) K893388 · Devilbiss Health Care, Inc.
510(k) numberK893388
Submission
- Device name
- Devilbiss Model 7351D Revitalizer CPAP System
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- May 1, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K961126 | Pulse Dose SeriesNFB · Traditional | 10/21/1996SE |
| K950849 | Model #7354BZD · Traditional | 02/08/1996SE |
| K952491 | Model 7355BZD · Traditional | 01/31/1996SE |
| K952249 | Jet NebulizerCAF · Traditional | 01/30/1996SE |
| K953815 | 5 LPM Oxygen ConcentratorCAW · Traditional | 11/09/1995SE |
| K952037 | 3 LPM Oxygen ConcentratorCAW · Traditional | 09/06/1995SE |
| K946095 | Devilbiss Model 5500CAF · Traditional | 08/24/1995SE |
| K944611 | Model# 7500 SurveyorMNR · Traditional | 04/21/1995SE |
Questions and answers
When was Devilbiss Model 7351D Revitalizer CPAP System cleared by the FDA?
Devilbiss Model 7351D Revitalizer CPAP System (K893388) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 53 days after the submission was received.
What is the product code of K893388?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.