Ultimate Seal
FDA 510(k) K960401 · Hans Rudolph, Inc.
510(k) numberK960401
Submission
- Device name
- Ultimate Seal
- Applicant
- Hans Rudolph, Inc.
Kansas City, MO, US - Received
- January 29, 1996
- Decision date
- June 20, 1996
- 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 |
| 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 |
| 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 |
More from Airlife, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071149 | Hri 6500, 6600 and 6700 Series V2MASKSBZD · Traditional | 02/01/2008SE |
| K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/Nppv MasksBZD · Traditional | 06/03/2003SE |
| K030515 | Hans Rudolph 7500 Series Reusable Oro-Nasal Niv MasksCBK · Traditional | 05/02/2003SE |
| K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640…BZD · Traditional | 08/13/2002SE |
| K962848 | Hans Rudolph Nasal CPAP MaskBYG · Traditional | 10/16/1996SE |
| K946077 | Directional Control Valves Inflatable Balloon-Type and ControllersBZC · Traditional | 09/15/1995SE |
| K945894 | Mask, Gas, AnestheticBSJ · Traditional | 01/27/1995SE |
| K933583 | Nonrebreathing ValveKGB · Traditional | 01/03/1994SE |
| K932147 | Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional | 08/20/1993SE |
| K791705 | 4200 Pneumatic Mouth ShutterCCM · Traditional | 10/04/1979SE |
Questions and answers
When was Ultimate Seal cleared by the FDA?
Ultimate Seal (K960401) received a 510(k) decision of Substantially Equivalent on June 20, 1996, 143 days after the submission was received.
What is the product code of K960401?
The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.