The following data is part of a premarket notification filed by Arthro-medic, Inc. with the FDA for Aqua+tfilterhme/thme/aqua+tfilterhch/thch.
| Device ID | K933597 |
| 510k Number | K933597 |
| Device Name: | AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | ARTHRO-MEDIC, INC. RISSNELEDEN 136 S-172 48 SUNDBYBERT Sweden, SE |
| Contact | Carol Hamilton |
| Correspondent | Carol Hamilton ARTHRO-MEDIC, INC. RISSNELEDEN 136 S-172 48 SUNDBYBERT Sweden, SE |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1993-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704399091 | K933597 | 000 |