510(k) K910262
- Device
- KELLER VITAL SIGNS MONITOR - KMS-890
- Applicant
- KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
- 510(k) number
- K910262
- Product code
- DSJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-01
- Date received
- 1991-01-22
- Regulation
- 870.1100
- Classification name
- Alarm, Blood-pressure
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY KELLER
- Address
- 42609 Crawford Rd. Antioch IL US 60002 60002
FDA Registration Numbers#
- 3003971136
- 3009077524
- 3003687189
- 3016701404
- 1316463
- 3013500228
- 3008058135
- 1218950
- 3012528160
- 3000126629
- 3016618143
- 9610816
- 3009831876
- 3009001657
- 9681377
- 2221819
- 1651104
- 1828100
- 3032109181
- 3008729547
- 3008716327
- 3016674095
- 3014541700
- 3015529350
- 3013679558
- 9610105
- 3007836437
- 3009156722
- 3013596024
- 3001570235
- 3004415095
- 3012359877
- 9710602
- 3019388613
- 3003263092
- 3008483389
- 3011353843
- 3004977335
- 3007603826
- 3005877899
- 3010698831
- 3013783488
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DSJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 |
| K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017-03-31 |
| K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015-09-29 |
| K133961 | SURESIGNS VS3, SURESIGNS VS4 | Philips Medical Systems | 2014-06-26 |
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | 3M Health Care, Sarns | 1996-06-04 |
Legacy Summary#
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FDA Review#
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