Laerdal(Tm) Pocket Mask, Modification
FDA 510(k) K933048 · Laerdal Medical Corp.
510(k) numberK933048
Submission
- Device name
- Laerdal(Tm) Pocket Mask, Modification
- Applicant
- Laerdal Medical Corp.
Armonk, NY, US - Received
- May 11, 1993
- Decision date
- December 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K932347 | Compact MaskKGB · Traditional | Vital Signs, Inc. | 01/10/1994SE |
| K933583 | Nonrebreathing ValveKGB · Traditional | Hans Rudolph, Inc. | 01/03/1994SE |
| 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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| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | 03/23/2018SE |
| K151702 | Reusable Full Silicone CoverLIX · Special | 08/13/2015SE |
| K001742 | Resusci Inflate-A-Shield CPR BarrierCBP · Traditional | 10/06/2000SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | 05/09/1996SE |
| K954609 | Heartstart 911MKJ · Traditional | 01/04/1996SE |
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Questions and answers
When was Laerdal(Tm) Pocket Mask, Modification cleared by the FDA?
Laerdal(Tm) Pocket Mask, Modification (K933048) received a 510(k) decision of Substantially Equivalent on December 2, 1993, 205 days after the submission was received.
What is the product code of K933048?
The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.