NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
FDA 510(k) clearance K851460 · decided 1985-05-10
Clearance details
- K-number
- K851460
- Device name
- NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
- Applicant
- Telectronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-11
- Decision date
- 1985-05-10
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- BXY
- Device class
- 1
- Regulation number
- 868.2350
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Suffield, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WESTMED RESPIRATORY LUER ADAPTOR (K953506) | Westmed Intl. | 1995-09-15 |
| PRECISION MEDICAL NEB BLOCK (K902916) | Precision Medical, Inc. | 1990-07-23 |
| PRECISION MEDICAL ELIMINATOR (K902917) | Precision Medical, Inc. | 1990-07-23 |
| OXY-OFF(TM) (K863510) | B&B Medical Technologies, Inc. | 1986-10-22 |
| LSP MINILATOR (K860516) | Life Support Products, Inc. | 1986-02-21 |
| PFT GASES (K781523) | Gardner Cryogenics | 1978-12-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S006) | Telectronics, Inc. | 1990-05-09 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S003) | Telectronics, Inc. | 1990-03-22 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S005) | Telectronics, Inc. | 1990-02-02 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S002) | Telectronics, Inc. | 1989-04-18 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S001) | Telectronics, Inc. | 1987-03-27 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027) | Telectronics, Inc. | 1986-09-30 |