510(k) K120764
- Device
- EPIFLO(R)
- Applicant
- NEOGENIX, LLC
- 510(k) number
- K120764
- Product code
- KPJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-27
- Date received
- 2012-03-13
- Regulation
- 878.5650
- Classification name
- Chamber, Oxygen, Topical, Extremity
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SRINIVASAN SARANGAPANI
- Address
- 3401 Enterprise Pkwy., Suite 340 Beachwood OH US 44122 44122
FDA Registration Numbers#
- 2027062
- 3010272829
- 3014767695
- 1924066
- 1314417
- 3008847017
- 3015423531
- 3004727093
- 3005144609
- 3008255748
- 3008139322
- 3038429246
- 3004036118
- 2030595
- 3003144120
- 3006538358
- 1720734
Source Documents#
Other 510(k) Records For Product Code KPJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | 2025-03-10 |
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023-03-23 |
| K190742 | EPIFLO-28 | Neogenix, LLC Dba Ogenix | 2019-12-13 |
| K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Inotec Amd , Ltd. | 2012-07-03 |
| K090681 | TANSCU O2 | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | 2008-08-06 |
| K050156 | WHS-1000 WOUND HEALING SYSTEM | Iyia Technologies, Inc. | 2005-06-17 |
| K023456 | OXYBOX SYSTEM | Oxyfast Corporation | 2003-02-24 |
| K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Vascular One, Inc. | 2002-12-17 |
| K020466 | HEC 1000 | Metro Medical Equipment, Inc. | 2002-05-08 |
| K002632 | OXYGENATOR | Adjunctive Therapeutics, Inc. | 2001-10-25 |
| K981949 | NUMOBAG | Numotech, Inc. | 1999-02-03 |
| K971507 | O2 BOOT | Gwr Medical, Llp | 1997-11-07 |
| K960756 | LIFETECH CASSETTE | Lifetech Systems, Inc. | 1997-08-29 |
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Stephenson Industries, Inc. | 1997-07-28 |
Legacy Summary#
summary
FDA Review#
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