The following data is part of a premarket notification filed by Narco Scientific with the FDA for Porta Fib Iii.
| Device ID | K822961 |
| 510k Number | K822961 |
| Device Name: | PORTA FIB III |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-05 |
| Decision Date | 1982-11-01 |