Anesthesia Face Mask
FDA 510(k) K953295 · Mallinckrodt Medical
510(k) numberK953295
Submission
- Device name
- Anesthesia Face Mask
- Applicant
- Mallinckrodt Medical
St Louis, MO, US - Received
- July 14, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSJ – Mask, Gas, Anesthetic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5550
- Specialty
- Anesthesiology
Other 510(k)s with product code BSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163277 | SuperNO2VA DeviceBSJ · Traditional | Revolutionary Medical Devices, Inc. | 10/13/2017SE |
| K953107 | Anesthesia/Respiratory Face MaskBSJ · Traditional | Medical Marketing Concepts | 08/15/1995SE |
| K952689 | Brigam Medical Disposable Anesthesia/Respiratory Face MaskBSJ · Traditional | Owens-Brigam Medical Co. | 07/11/1995SE |
| K951043 | Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskBSJ · Traditional | Promedic, Inc. | 06/07/1995SE |
| K950771 | Disposable Adhesive Face MaskBSJ · Traditional | Advanced Warming Systems, Inc. | 03/10/1995SE |
| K945894 | Mask, Gas, AnestheticBSJ · Traditional | Hans Rudolph, Inc. | 01/27/1995SE |
| K945440 | Disposable, Anesthesia/Respiratory Face MaskBSJ · Traditional | Fvtnks | 11/08/1994SE |
| K944157 | Disposable, Preformed Face MaskBSJ · Traditional | Meridian Medical Systems, Inc. | 10/03/1994SE |
| K932147 | Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional | Hans Rudolph, Inc. | 08/20/1993SE |
| K932014 | Ambu Disposable Face MaskBSJ · Traditional | Ambu, Inc. | 06/22/1993SE |
More from Ambu, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082520 | Sealguard Evac Endotracheal and Endotracheal TubesBTR · Special | 10/02/2008SE |
| K051416 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaJOH · Special | 06/16/2005SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | 12/29/1997SE |
| K971267 | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…JOH · Traditional | 09/25/1997SE |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…JOH · Traditional | 06/26/1997SE |
| K955721 | Cuffed Oropharyngeal Airway (Copa)CAE · Traditional | 03/28/1997SE |
| K965132 | Hi-Lo Evac and Evac II Endotracheal TubesBTR · Traditional | 03/20/1997SE |
| K962045 | Anesthesia Breathing Circuit/Anesthesia Breathing KitCAH · Traditional | 11/26/1996SE |
| K962173 | Shikey Tracheostomy Tubes and AccessoriesJOH · Traditional | 10/04/1996SE |
| K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedJOH · Traditional | 03/13/1996SE |
Questions and answers
When was Anesthesia Face Mask cleared by the FDA?
Anesthesia Face Mask (K953295) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 28 days after the submission was received.
What is the product code of K953295?
The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.