The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Model 90421 Flexport Interface.
Device ID | K903702 |
510k Number | K903702 |
Device Name: | MODEL 90421 FLEXPORT INTERFACE |
Classification | Oximeter |
Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Contact | Raymond W Gifford |
Correspondent | Raymond W Gifford SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-31 |
Decision Date | 1990-10-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522105098 | K903702 | 000 |
10841522106316 | K903702 | 000 |
10841522106323 | K903702 | 000 |
10841522106330 | K903702 | 000 |
10841522106347 | K903702 | 000 |
10841522106361 | K903702 | 000 |
10841522106378 | K903702 | 000 |
10841522106392 | K903702 | 000 |
10841522106408 | K903702 | 000 |
10841522105128 | K903702 | 000 |
10841522105135 | K903702 | 000 |
10841522105142 | K903702 | 000 |
10841522105159 | K903702 | 000 |
10841522105180 | K903702 | 000 |
10841522129063 | K903702 | 000 |
10841522100062 | K903702 | 000 |