The following data is part of a premarket notification filed by Inovo, Inc. with the FDA for Inovo, Inc, Economizer Conserving Regulator.
Device ID | K031983 |
510k Number | K031983 |
Device Name: | INOVO, INC, ECONOMIZER CONSERVING REGULATOR |
Classification | Conserver, Oxygen |
Applicant | INOVO, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk INOVO, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-26 |
Decision Date | 2003-09-15 |
Summary: | summary |