New Connector & Cover for Telectronics 8MM Unipola
FDA 510(k) K851460 · Telectronics, Inc.
510(k) numberK851460
Submission
- Device name
- New Connector & Cover for Telectronics 8MM Unipola
- Applicant
- Telectronics, Inc.
Suffield, CT, US - Received
- April 11, 1985
- Decision date
- May 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXY – Flowmeter, Calibration, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2350
- Specialty
- Anesthesiology
Other 510(k)s with product code BXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953506 | Westmed Respiratory Luer AdaptorBXY · Traditional | Westmed Intl. | 09/15/1995SE |
| K902917 | Precision Medical EliminatorBXY · Traditional | Precision Medical, Inc. | 07/23/1990SE |
| K902916 | Precision Medical Neb BlockBXY · Traditional | Precision Medical, Inc. | 07/23/1990SE |
| K863510 | Oxy-Off(Tm)BXY · Traditional | B&B Medical Technologies, Inc. | 10/22/1986SE |
| K860516 | LSP MinilatorBXY · Traditional | Life Support Products, Inc. | 02/21/1986SE |
| K781523 | PFT GasesBXY · Traditional | Gardner Cryogenics | 12/01/1978SE |
More from Gardner Cryogenics
| 510(k) | Device | Decision |
|---|---|---|
| K890895 | Implantable Adaptor 033-380DTD · Traditional | 03/06/1990SE |
| K891231 | Optima MPT and SPT PacemakersDXY · Traditional | 09/12/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | 02/02/1989SE |
| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | 12/15/1988SE |
| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | 12/17/1987SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | 08/18/1987SE |
Questions and answers
When was New Connector & Cover for Telectronics 8MM Unipola cleared by the FDA?
New Connector & Cover for Telectronics 8MM Unipola (K851460) received a 510(k) decision of Substantially Equivalent on May 10, 1985, 29 days after the submission was received.
What is the product code of K851460?
The FDA product code is BXY – Flowmeter, Calibration, Gas, a Class I (low risk) device regulated under 21 CFR 868.2350.