Atlas FDA

SIEMENS SC9000/SC9015 TCP02/C02 MODULE

FDA 510(k) clearance K980287 · decided 1998-08-12

Clearance details

K-number
K980287
Device name
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1998-01-26
Decision date
1998-08-12
Days to decision
198 days
Clearance type
Traditional
Product code
KLK
Device class
2
Regulation number
868.2500
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (K870805)Novametrix Medical Systems, Inc.1987-05-27
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HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (K860124)Mennen Medical, Inc.1986-05-09
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21