Arterial Blood Gassing Monitoring System (Abg)
FDA 510(k) K870016 · Migada, Ltd.
510(k) numberK870016
Submission
- Device name
- Arterial Blood Gassing Monitoring System (Abg)
- Applicant
- Migada, Ltd.
Israel, IL - Received
- January 2, 1987
- Decision date
- May 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTB – Permanent Pacemaker Electrode
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DTB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061212 | Biotronik Endocardial Pacing LeadsDTB · Special | Biotronik, Inc. | 07/10/2006SE |
| K041809 | Permanent Pacing Lead, Model PY2DTB · Special | Oscor, Inc. | 08/06/2004SE |
| K040569 | Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, RjuDTB · Special | Oscor, Inc. | 04/07/2004SE |
| K031274 | Model 5071 Myocardial Pacing LeadDTB · Special | Medtronic Vascular | 05/22/2003ST |
| K031210 | Model 4951M Myocardial Unipolar LeadDTB · Special | Metronic, Inc. | 05/16/2003SE |
| K023205 | Elox P 45-BP; Elox P 53-BP; Elox P 60-BPDTB · Traditional | Biotronik, Inc. | 04/24/2003ST |
| K024053 | Permanent Pacing Leads, Models Physique PB and PJBDTB · Special | Oscor, Inc. | 01/31/2003SE |
| K023803 | Modification to Biotronik's Sterilization ProcessDTB · Special | Biotronik, Inc. | 12/11/2002SE |
| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special | Biotronik, Inc. | 10/18/2002SE |
| K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special | Biotronik, Inc. | 05/01/2002SE |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954883 | Free Flow Safety DeviceFPA · Traditional | 04/23/1996SE |
| K943095 | IV Transfer SpikeLHI · Traditional | 09/30/1994SE |
| K933929 | Lab-Site(R) Safety CannulaCBF · Traditional | 12/07/1993SE |
| K902881 | Lab-Site Safety NeedleCBT · Traditional | 09/26/1990SE |
| K864453 | Emergency & Military Infusion SystemFPA · Traditional | 01/20/1987SE |
| K863304 | Preselected Flow Rate I.V. SetFPA · Traditional | 12/09/1986SE |
| K860952 | I.V. Set with and Without Air VentFPA · Traditional | 08/27/1986SE |
| K861275 | High Flow I.V. SetFPA · Traditional | 06/02/1986SE |
| K860595 | Transfer SetLHI · Traditional | 04/07/1986SE |
| K860605 | Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic FilterFPA · Traditional | 03/24/1986SE |
Questions and answers
When was Arterial Blood Gassing Monitoring System (Abg) cleared by the FDA?
Arterial Blood Gassing Monitoring System (Abg) (K870016) received a 510(k) decision of Substantially Equivalent on May 28, 1987, 146 days after the submission was received.
What is the product code of K870016?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.