FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELSTAR PREWIRE SERIES
K Number: K871731
·
Decision Oct 27, 1987
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
11
Review Days
175
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TELSTAR PREWIRE SERIES
- K Number
- K871731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Telstar Electronics, Inc.
- Date Received
- May 5, 1987
- Decision Date
- October 27, 1987
- Product Code
- LRS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRS), ordered by most recent decision date.
AMSINO I.V. START KIT
FDA 510(k)
FDA Class 2
·General Hospital
INFUSION IV SET
FDA 510(k)
FDA Class 2
·General Hospital
IV START KIT
FDA 510(k)
FDA Class 2
·General Hospital
EMS I.V. START KIT
FDA 510(k)
FDA Class 2
·General Hospital
B. BRAUN IV START KITS
FDA 510(k)
FDA Class 2
·General Hospital
PERSONAL HEARING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Telstar Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892459 | TELSTAR MODEL C ITE HEARING AID | Jun 6, 1989 | Substantially Equivalent |
| K892458 | TELSTAR MODEL F ITE HEARING AID | Jun 6, 1989 | Substantially Equivalent |
| K892460 | TELSTAR MODEL PP ITE HEARING AID | Jun 6, 1989 | Substantially Equivalent |
| K892457 | TELSTAR MODEL 1/3 ITE HEARING AID | Jun 6, 1989 | Substantially Equivalent |
| K873210 | TELSTAR MODEL PP | Sep 29, 1987 | Substantially Equivalent |
| K871520 | TELSTAR MODEL FS HEARING AID | Jun 8, 1987 | Substantially Equivalent |
| K871521 | FULL SHELL ITE HEARING AID | Jun 5, 1987 | Substantially Equivalent |
| K871522 | TELSTAR MODEL C HEARING AID | Jun 5, 1987 | Substantially Equivalent |
| K871518 | TELSTAR MODEL F3TS HEARING AID | Jun 5, 1987 | Substantially Equivalent |
| K871519 | TELSTAR MODEL 0/3 HEARING AID | May 19, 1987 | Substantially Equivalent |