The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Pressure Limiting Elbow With Manometer Port.
| Device ID | K911298 |
| 510k Number | K911298 |
| Device Name: | PRESSURE LIMITING ELBOW WITH MANOMETER PORT |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Debra E Rogers |
| Correspondent | Debra E Rogers INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-06-25 |