OXYGEN CATHETERS
FDA 510(k) clearance K896731 · decided 1990-03-30
Clearance details
- K-number
- K896731
- Device name
- OXYGEN CATHETERS
- Applicant
- Unoplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1989-11-30
- Decision date
- 1990-03-30
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- BZB
- Device class
- 1
- Regulation number
- 868.5350
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Denmark, DK
- 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 |
|---|---|---|
| PHARMA-PLAST OXYGEN CATHETER (K843466) | Zimmar Consulting , Ltd. | 1984-11-19 |
| DEMAND OXYGEN CONTROLLER (K833351) | Healthdyne, Inc. | 1984-03-19 |
| OXYGEN CATHETERS (K830984) | Medovations, Inc. | 1983-05-18 |
| NASAL OXYGEN CATHETER (K820370) | American Pharmaseal Div. Ahsc | 1982-04-16 |
| OXYGEN CATHETER (K800506) | Medi-Craft , Ltd. | 1980-03-25 |
| CONPHAR OXYGEN CATHETER-STERILE (K791273) | Conphar, Inc. | 1979-07-24 |
| CATHETER, OXYGEN (K790057) | Medline Industries, Inc. | 1979-02-05 |
Recalls involving this device
No recalls on record reference this clearance.