The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Ir Pro 250.
Device ID | K061080 |
510k Number | K061080 |
Device Name: | IR PRO 250 |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
Contact | Mark W Sheehan |
Correspondent | Mark W Sheehan LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-18 |
Decision Date | 2006-06-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IR PRO 250 78954998 3344276 Dead/Cancelled |
Lhasa OMS, Inc. 2006-08-18 |