The following data is part of a premarket notification filed by Altimate Medical, Inc. with the FDA for Bantam.
Device ID | K091242 |
510k Number | K091242 |
Device Name: | BANTAM |
Classification | Chair, Positioning, Electric |
Applicant | ALTIMATE MEDICAL, INC. ONE INVACARE WAY Elyria, OH 44035 -4190 |
Contact | Caroll L Martin |
Correspondent | Caroll L Martin ALTIMATE MEDICAL, INC. ONE INVACARE WAY Elyria, OH 44035 -4190 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-28 |
Decision Date | 2009-07-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10858921006079 | K091242 | 000 |
10858921006062 | K091242 | 000 |