The following data is part of a premarket notification filed by Ssi Medical Services, Inc. with the FDA for Clinitron Elexis.
Device ID | K943385 |
510k Number | K943385 |
Device Name: | CLINITRON ELEXIS |
Classification | Bed, Air Fluidized |
Applicant | SSI MEDICAL SERVICES, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
Contact | Thomas E Mcfadden |
Correspondent | Thomas E Mcfadden SSI MEDICAL SERVICES, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-13 |
Decision Date | 1995-02-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLINITRON ELEXIS 74199790 1777211 Dead/Cancelled |
PATHMARK COMPANY, INC. 1991-09-03 |