The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Cam 4 Thermoelectric Child/adult Mist Tent.
| Device ID | K941547 |
| 510k Number | K941547 |
| Device Name: | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT |
| Classification | Tent, Oxygen, Electrically Powered |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Contact | Wayne Karcher |
| Correspondent | Wayne Karcher ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Product Code | BYK |
| CFR Regulation Number | 868.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-30 |
| Decision Date | 1995-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720001644 | K941547 | 000 |
| 00260720001637 | K941547 | 000 |
| 00260720001620 | K941547 | 000 |
| 00026072001646 | K941547 | 000 |
| 00026072001639 | K941547 | 000 |
| 00026072001622 | K941547 | 000 |