510(k) K843466
K843466 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST OXYGEN CATHETER". The FDA issued a decision of Substantially Equivalent on November 19, 1984. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1984
- Date Received
- September 6, 1984
- 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