NASAL OXYGEN CATHETER
FDA 510(k) clearance K820370 · decided 1982-04-16
Clearance details
- K-number
- K820370
- Device name
- NASAL OXYGEN CATHETER
- Applicant
- American Pharmaseal Div. Ahsc
- Decision
- Substantially Equivalent
- Date received
- 1982-02-09
- Decision date
- 1982-04-16
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- BZB
- Device class
- 1
- Regulation number
- 868.5350
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American Pharmaseal Div. Ahsc
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OXYGEN CATHETERS (K896731) | Unoplast A/S | 1990-03-30 |
| 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 |
| 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.