Modified Touch-Me-Not Mask
FDA 510(k) K884157 · Walt'S Products
510(k) numberK884157
Submission
- Device name
- Modified Touch-Me-Not Mask
- Applicant
- Walt'S Products
Winston-Salem, NC, US - Received
- October 4, 1988
- Decision date
- August 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
Questions and answers
When was Modified Touch-Me-Not Mask cleared by the FDA?
Modified Touch-Me-Not Mask (K884157) received a 510(k) decision of Substantially Equivalent on August 21, 1989, 321 days after the submission was received.
What is the product code of K884157?
The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.