510(k) K881393
K881393 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "RONDEX RESCUE MASK". The FDA issued a decision of Substantially Equivalent on April 25, 1988. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1988
- Date Received
- April 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Gas, Anesthetic
- Device Class
- Class I
- Regulation Number
- 868.5550
- Review Panel
- AN
- Submission Type