510(k) K833351
K833351 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "DEMAND OXYGEN CONTROLLER". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1984
- Date Received
- September 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5350
- Review Panel
- AN
- Submission Type