Air-Soft-Disposable, Anesthesisa/Respiratory Face Mask
FDA 510(k) K951043 · Promedic, Inc.
510(k) numberK951043
Submission
- Device name
- Air-Soft-Disposable, Anesthesisa/Respiratory Face Mask
- Applicant
- Promedic, Inc.
Indianapolis, IN, US - Received
- March 7, 1995
- Decision date
- June 7, 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
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|---|---|---|---|
| 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 |
| 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 |
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| K072756 | Non-Iv Adapter for Infant NG TubeKNT · Traditional | 12/19/2007SESK |
| K060497 | BabyairCAF · Traditional | 07/11/2006SE |
| K060842 | Revjet TurboCAF · Traditional | 06/21/2006SE |
| K052903 | Pediatric Feeding TubeKNT · Traditional | 11/09/2005SE |
| K031409 | Urinary CathetersGBM · Traditional | 06/17/2003SE |
| K024190 | Fenestrated Infusion CatheterFRN · Traditional | 03/17/2003SE |
| K023579 | Gas Sampling LinesCCK · Traditional | 01/28/2003SE |
| K020005 | Infant Feeding TubesKNT · Traditional | 07/16/2002SE |
Questions and answers
When was Air-Soft-Disposable, Anesthesisa/Respiratory Face Mask cleared by the FDA?
Air-Soft-Disposable, Anesthesisa/Respiratory Face Mask (K951043) received a 510(k) decision of Substantially Equivalent on June 7, 1995, 92 days after the submission was received.
What is the product code of K951043?
The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.