Compact Mask
FDA 510(k) K932347 · Vital Signs, Inc.
510(k) numberK932347
Submission
- Device name
- Compact Mask
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- May 14, 1993
- Decision date
- January 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGB – Mask, Oxygen, Non-Rebreathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5570
- Specialty
- Anesthesiology
Other 510(k)s with product code KGB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970688 | Pocket RescueKGB · Traditional | Cheen Houng Ent. Co. , Ltd. | 09/26/1997SE |
| K960401 | Ultimate SealKGB · Traditional | Hans Rudolph, Inc. | 06/20/1996SE |
| K941336 | Combo MaskKGB · Traditional | Gam Industries, Inc. | 09/09/1994SE |
| K935917 | Challenge Powder-Free, Hypoallergenic, Synthetic Surgical GlovesKGB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1994SE |
| K933583 | Nonrebreathing ValveKGB · Traditional | Hans Rudolph, Inc. | 01/03/1994SE |
| K933048 | Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional | Laerdal Medical Corp. | 12/02/1993SE |
| K930336 | Profast(R)-Denture Adhesive CreamKGB · Traditional | Fittydent-Altwirth & Schmitt GmbH | 08/24/1993SE |
| K913164 | Non Rebreathing MaskKGB · Traditional | Specialty Packaging Producs, Inc. | 01/15/1992SE |
| K883766 | Mouth-To-Mask Ventilatory AdjunctKGB · Traditional | Medic One | 10/21/1988SE |
| K790162 | Oxygen Mask, Concentration Aerosol MaskKGB · Traditional | Airlife, Inc. | 04/20/1979SE |
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| K022402 | Disposable Pressure ManometerCAP · Traditional | 08/22/2002SE |
| K021315 | Sure-LokFMI · Abbreviated | 08/21/2002SE |
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| K001553 | Breas PV 100 CPAP SystemBZD · Traditional | 08/03/2000SE |
| K000441 | BodyguardFMI · Traditional | 04/11/2000SE |
| K994044 | Cleen-AbleDXQ · Traditional | 02/25/2000SE |
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Questions and answers
When was Compact Mask cleared by the FDA?
Compact Mask (K932347) received a 510(k) decision of Substantially Equivalent on January 10, 1994, 241 days after the submission was received.
What is the product code of K932347?
The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.