The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Spirometer, Incentive Catalog # 1750.
Device ID | K781831 |
510k Number | K781831 |
Device Name: | SPIROMETER, INCENTIVE CATALOG # 1750 |
Classification | Spirometer, Therapeutic (incentive) |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BWF |
CFR Regulation Number | 868.5690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-30 |
Decision Date | 1978-12-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
34026704630111 | K781831 | 000 |
24026704595536 | K781831 | 000 |
24026704390513 | K781831 | 000 |