Siemens Medical Electronics
Danvers, MA, US
Siemens Medical Electronics appears in FDA device records in Danvers, MA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Siemens Medical Electronics between 1988 and 1995. The busiest year on record is 1989, with 5. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 5 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K935043 | SIEMENS CLINICAL WORK STATION | DQK | Substantially Equivalent | |
| K921930 | SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI | DPS | Substantially Equivalent | |
| K920445 | SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES | MHX | Substantially Equivalent | |
| K914765 | SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS | DXN | Substantially Equivalent | |
| K912070 | SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT | GEI | Substantially Equivalent | |
| K913489 | SIEMENS MICRO2 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K905775 | SIEMENS ETCO2 CARTRIDGE | CCK | Substantially Equivalent | |
| K900319 | SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM | DSI | Substantially Equivalent | |
| K901771 | SIEMENS SIRECUST 732, PATIENT MONITOR | DPS | Substantially Equivalent | |
| K894460 | SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA | DSI | Substantially Equivalent | |
| K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | LKD | Substantially Equivalent | |
| K893470 | SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE | DQA | Substantially Equivalent | |
| K891023 | SIEMENS CEILING STAND 800F, 800 AND 810 | LDQ | Substantially Equivalent | |
| K890791 | SIEMENS SIRECUST 730 PATIENT MONITOR | DPS | Substantially Equivalent | |
| K881939 | SIRECUST 1280/1281 & 960/961 PATIENT MONITORS | DPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LKDMonitor, Carbon-Dioxide, Cutaneous
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Siemens Medical Electronics edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Siemens Medical Electronics. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain
