Anesthesia/Respiratory Face Mask
FDA 510(k) K953107 · Medical Marketing Concepts
510(k) numberK953107
Submission
- Device name
- Anesthesia/Respiratory Face Mask
- Applicant
- Medical Marketing Concepts
Hardy, VA, US - Received
- July 3, 1995
- Decision date
- August 15, 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 |
| K953295 | Anesthesia Face MaskBSJ · Traditional | Mallinckrodt Medical | 08/11/1995SE |
| 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 |
|---|---|---|
| K982215 | Manual Resuscitator with AceBTM · Traditional | 09/18/1998SE |
| K961867 | Peep ValveBYE · Traditional | 08/13/1996SE |
| K961330 | Bagright Infant ResuscitatorBTM · Traditional | 07/02/1996SE |
| K961329 | Bagright Child ResuscitatorBTM · Traditional | 07/02/1996SE |
| K961882 | Resposable Infant ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961868 | Resposable Child ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961369 | Bagright Resposable ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961332 | Bagright Resposable Infant ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961331 | Bagright Resposable Child ResuscitatorBTM · Traditional | 06/28/1996SE |
| K953546 | Manual Pulmonary ResusicitatorBTM · Traditional | 02/29/1996SE |
Questions and answers
When was Anesthesia/Respiratory Face Mask cleared by the FDA?
Anesthesia/Respiratory Face Mask (K953107) received a 510(k) decision of Substantially Equivalent on August 15, 1995, 43 days after the submission was received.
What is the product code of K953107?
The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.