CYL-FIL OXYGEN SYSTEM
FDA 510(k) clearance K061785 · decided 2006-09-07
Clearance details
- K-number
- K061785
- Device name
- CYL-FIL OXYGEN SYSTEM
- Applicant
- Responsive Respiratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-23
- Decision date
- 2006-09-07
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- CAN
- Device class
- 1
- Regulation number
- 868.2700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MR Conditional CGA 870 (K162811) | Essex Industries, Inc. | 2017-03-02 |
| PORTABLE OXYGEN UNIT SCA900 (K080243) | San Cheong Co. , Ltd. | 2009-04-07 |
| REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (K060265) | Remcore, Inc. | 2006-10-25 |
| OXYGEN REGULATOR (K950777) | Mada Medical Products, Inc. | 1995-04-14 |
| VANGUARD SERIES GAS REGULATORS (K942751) | Buckman Co., Inc. | 1995-02-09 |
| LSPI PRESSURE REGULATOR (K936187) | Life Support Products, Inc. | 1994-01-27 |
| 1500 SERIES REGULATOR (K932006) | Precision Medical, Inc. | 1993-10-25 |
| AMBU OXYGEN REGULATOR (K921125) | Amg, LLC | 1992-09-17 |
| GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (K915154) | C.G.H. Medical, Inc. | 1992-05-27 |
| REGULATOR FLOWMETER (K915505) | Lifeguard Medical Products, Inc. | 1992-04-22 |
| GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (K914271) | C.G.H. Medical, Inc. | 1992-04-13 |
| SALTER LABS DISPOSABLE NIPPLE AND NUT (K912174) | Salter Labs | 1991-07-24 |
Recalls involving this device
No recalls on record reference this clearance.