510(k) K760816
K760816 is an FDA 510(k) premarket notification submitted by Aftercal, Inc. for the device "PNEUMOTACHOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 1976. The device falls under product code GWB (Antisera, Fluorescent, All Types, Streptococcus Pneumoniae), a Class I device regulated under 21 CFR 866.3740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1976
- Date Received
- October 12, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type