The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Manual Resuscitator Bag.
| Device ID | K993194 |
| 510k Number | K993194 |
| Device Name: | RUSCH MANUAL RESUSCITATOR BAG |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Contact | Ronald Young |
| Correspondent | Ronald Young RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-23 |
| Decision Date | 2000-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627843557579 | K993194 | 000 |
| 24026704645699 | K993194 | 000 |
| 24026704645682 | K993194 | 000 |
| 24026704645668 | K993194 | 000 |
| 24026704645651 | K993194 | 000 |
| 24026704645644 | K993194 | 000 |
| 24026704645675 | K993194 | 000 |
| B0024050UP3 | K993194 | 000 |
| B0024025UP3 | K993194 | 000 |
| B0024010UP3 | K993194 | 000 |
| B0024000UP3 | K993194 | 000 |
| B0024000F0 | K993194 | 000 |
| B00240000 | K993194 | 000 |
| B0024000U0 | K993194 | 000 |
| 00627843557562 | K993194 | 000 |
| 00627843557555 | K993194 | 000 |
| 00627843557548 | K993194 | 000 |
| 00627843557531 | K993194 | 000 |
| 00627843557524 | K993194 | 000 |
| B0024050U3 | K993194 | 000 |
| B00240506 | K993194 | 000 |
| B0024025U0 | K993194 | 000 |
| B00240256 | K993194 | 000 |
| B0024010U3 | K993194 | 000 |
| B00240100 | K993194 | 000 |
| B0024050RB7 | K993194 | 000 |