The following data is part of a premarket notification filed by Anesthesia Assoc., Inc. with the FDA for Jet Ventilator/jetting Device.
| Device ID | K921926 |
| 510k Number | K921926 |
| Device Name: | JET VENTILATOR/JETTING DEVICE |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | ANESTHESIA ASSOC., INC. 460 ENTERPRISE ST. San Marcos, CA 92078 |
| Contact | Donald R Rowean |
| Correspondent | Donald R Rowean ANESTHESIA ASSOC., INC. 460 ENTERPRISE ST. San Marcos, CA 92078 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-24 |
| Decision Date | 1992-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B00500325S0 | K921926 | 000 |
| B00500325LPEXT2MM0 | K921926 | 000 |
| B005P2190 | K921926 | 000 |
| B005003250 | K921926 | 000 |
| B00500325HP0 | K921926 | 000 |
| B00500325HPS0 | K921926 | 000 |
| B00500325LP0 | K921926 | 000 |
| B00500325LPEXT20 | K921926 | 000 |
| B00500325LPEXT40 | K921926 | 000 |
| B00500325LPS0 | K921926 | 000 |
| B00500325MRI0 | K921926 | 000 |
| B00500325MRIHP0 | K921926 | 000 |
| B00500325MRIHPS0 | K921926 | 000 |
| B00500325MRILP0 | K921926 | 000 |
| B00500325MRILPS0 | K921926 | 000 |
| B00500325MRIS0 | K921926 | 000 |
| B00500325LPEXT10 | K921926 | 000 |