Accutron Pollution Reducer
FDA 510(k) K790638 · Parker Laboratories, Inc.
510(k) numberK790638
Submission
- Device name
- Accutron Pollution Reducer
- Applicant
- Parker Laboratories, Inc.
Mchenry, IL, US - Received
- March 30, 1979
- Decision date
- May 25, 1979
- 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 |
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| K233965 | UltraDrape UGPIV Barrier and Securement (34-15)ITX · Traditional | 08/15/2024SE |
| K953673 | Eclipse Probe CoverIYO · Traditional | 03/14/1996SE |
| K921695 | Ultra Cover Ultrasound Transducer Probe CoversITX · Traditional | 02/23/1995SE |
| K864556 | Aqualube(Tm)KMJ · Traditional | 12/01/1986SE |
| K861239 | Acrylic SolderEBI · Traditional | 04/17/1986SE |
| K855167 | Dyna SystemEGG · Traditional | 03/04/1986SE |
| K851895 | Polygel Ultrasound GelIYO · Traditional | 09/27/1985SE |
| K852956 | Contact Conductive Adhesive Gel CompositionGYB · Traditional | 08/09/1985SE |
| K841400 | Neuro PulseGZJ · Traditional | 06/15/1984SE |
| K840548 | ResilEBI · Traditional | 04/17/1984SE |
Questions and answers
When was Accutron Pollution Reducer cleared by the FDA?
Accutron Pollution Reducer (K790638) received a 510(k) decision of Substantially Equivalent on May 25, 1979, 56 days after the submission was received.
What is the product code of K790638?
The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.