510(k) K193646
- Device
- Dynamic Gas Scavenging System 2 (DGSS - 2)
- Applicant
- Anesthetic Gas Reclamation, Inc.
- 510(k) number
- K193646
- Product code
- CBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-12-04
- Date received
- 2019-12-30
- Regulation
- 868.5430
- Classification name
- Apparatus, Gas-scavenging
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- James Berry
- Address
- 10606 Shady Trl. #22 Dallas TX US 75220 75220
FDA Registration Numbers#
- 3011137372
- 3004365956
- 3010396502
- 2022648
- 3007143859
- 3003898360
- 2243990
- 9617604
- 2020813
- 3005724505
- 2112667
- 3008776780
- 2518157
- 3013682776
Source Documents#
Other 510(k) Records For Product Code CBN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223452 | Nitronox Scavenger Plus | Parker Hannifin Corporation | 2023-03-05 |
| K160950 | MINISCAV | Sedation Systems, LLC | 2017-05-05 |
| K142138 | ISO-GARD MASK | Teleflexmedical, Inc. | 2014-10-30 |
| K132729 | ISO-GARD MASK | Teleflexmedical, Inc. | 2014-01-09 |
| K123176 | ISO-GARD CLEARAIR MASK | Teleflexmedical, Inc. | 2013-02-14 |
| K110930 | ACTIVE WASTE GAS SCAVENGER | G. Dundas Co.,Inc. | 2011-06-23 |
| K092031 | VAPOR-CLEAR, MODEL 100 | Axon Medical, Inc. | 2010-04-16 |
| K080039 | PASSIVE WASTE GAS SCAVENGER, MODEL 14600 | G. Dundas Co.,Inc. | 2008-04-14 |
| K072255 | MINRAD INC. NASAL SCAVENGING CIRCUIT | Minrad, Inc. | 2007-10-18 |
| K063519 | DYNAMIC GAS SCAVENGING SYSTEM (DGSS) | Anesthetic Gas Reclamation, LLC | 2006-12-01 |
| K033028 | ANEFIN, MODEL 100 | Axon Medical | 2005-07-22 |
| K033503 | RFS VACUUM GAUGE SCAVENGING CIRCUIT | Accutron, Inc. | 2004-03-12 |
| K981754 | AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 | Porter Instrument Co., Inc. | 1998-06-16 |
| K963601 | MODEL 1920 WASTE GAS SCAVENGER | G. Dundas Co. | 1997-04-28 |
| K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) | Accutron, Inc. | 1997-03-28 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases